Biological Safety ProgrammeQFI’s Biological Safety Programme evaluates composition of raw materials, intermediate and finished products ranging from permanent implants
Brexit medical device risk assessmentQFI launched the first specially-devised and dedicated Brexit medical device support service, to prepare manufacturer’s and other medical device economic
CE- SearchCE-Search is a subscription or pay-per article search of CE marking status of medical devices. CE-Search offers increased functionality to subscribes and other
Clinical Evaluation ProgrammeQFI specialises in devising and producing high-calibre clinical data to fulfil European and other medical device legislation. Our clinical evaluation programme offers full package
Clinical Trials ProgramIn order to market a medical device intended for human therapeutic use, a regulatory body requires evidence that it is both safe and effective.
Corporate Excellence ProgrammeQFI specialises in devising and producing high-calibre clinical data to fulfil European and other medical device legislation. Our clinical evaluation programme offers full package
EU Authorised Data Protection Representative Programme (EUADPRP)A company supplying products and services to customers in the European Union that does not have an office or is not established in any EU Member State or in the United Kingdom
Expert Witness ProgrammeQFI offers an unbiased Expert Witness service in support of: • Defence/Prosecution • Independent Review • Criminal/Civil • Analytical Investigation • Liability/Negligence
Labour Standards Assurance System Programme
Medical Device Business Segment servicesQFI’s environmental management system unites global and sectorial legislation, initiative, policies and standards in a seamless, integrated programme
Medical Device Environmental Waste Management ProgrammeQFI’s environmental waste management system unites global and sectorial legislation, initiative, policies and standards in a seamless, integrated programme to assist
Medical device risk assessmentA wide range of medical devices, especially high-risk, orthopaedic, cardiology, radiology, biomaterials, permanent implants, infusion & transfusion, medical electronics
Microbiology Advisory ProgramDevelopment of an effective contamination control system is essential in aseptic, terminally sterilised and non-sterile medical device manufacture also many re-useable
Product complaint handling ServicesQFI offers a wide-range of market surveillance and product complaint handling services. For manufacturers and other medical device economic operators
Registar* – Medical Device RegistrationRegistar* is the programme from Quality First International that registers medical devices with any country in the world. QFI identifies
Remedium ProgrammeEvery medical device manufacturer regardless of company size or the sophistication of their product will at some point find themselves out of compliance with
Scientific and clinical literature servicesQFI is a leading provider of scientific and clinical literature research on medical devices. We produce high-calibre grounded-theory, thematic and phenomenological
StandardSearch ProgrammeQFI offers a unique Standards update and review service for medical devices through our Standards Search Programme that ensures rigorous and accurate conformity
Usability and human factors engineeringMedical devices generally possess inherent or intuitive usability properties and characteristics typically originating at manifestations known or believed typical
Biological Safety Programme
- Description of product in technical detail sufficient and as relevant to understand:
- Materials of construction (including ancillary materials, particularly, surface treatments, adhesives, etc)
- Mode of contact with the body (eg, percutaneous, circulating blood, central circulation, tissue, organ etc)
- Duration of contact intended by the Manufacturer (including any discontinuous use)
- Relevant information including reference device that may be relied whether made by the Manufacturer or competitor
- Factors that could lead or accelerate degradation in vivo (eg, radiation, including ultra-violet, radio waves, plasma, elevated temperature etc); method of sterilisation
QFI conducts biological evaluation according to §3.1 and §3.2 EN ISO 10993-1 + FDA guidance, as appropriate, considering absolute and relative concentrations of known toxic materials, compounds, materials in the device and method of manufacture, etc.
QFI can also audit biological safety assessment provisions applied to medical devices and device-drug combinations.
QFI is able to investigate and guide remedies when excursions in the biological safety profile of products occur, including evaluation of the merits of analytical techniques and standard methods.
Further, QFI can assist in correct design of test conditions, guide judicious selection and waiver of tests depending on the state-of-the-Art and constructive knowledge.
QFI is adept at fundamental research of biological safety data to guide logical decisions in selecting and combining bio-materials and help to limit risk of regulatory exposure.
Brexit medical device risk assessment
Our Brexit risk assessment scrutinises entire economic chain, organisation and product technology identify improvements and contingencies to transpire. Where instructed, QFI can produce full set of documents to allow medical devices to remain on the respective markets.
Our in depth, critical Brexit risk assessment report can serve as the basis for transition, thereby assisting manufacturers and other medical device economic operators to continue to trade unhindered.
If you are involved in supplying finished product, intermediate product or raw materials, perform sub-contract operations for other medical device manufactures or manufacture or assemble, design, service or repair medical devices and equipment, our Brexit risk assessment and solutions are ideal at all supply chain levels.
QFI can also formulate Brexit contingency plans and where required, remediate deficiencies via our Remedium programme.
CE-Search offers increased functionality to subscribes and other enquires by allowing verification of CE marking status of medical device, manufactures details, CE marking history and other important facts, such as classification and where relevant, notified body and countries supplied.
Clinical Evaluation Programme
Our experienced specialists formulate clinical evaluation plans, guide sub-ordinate clinical development and complement these by robust evidence-based research linked to compliant market surveillance system elements.
QFI produces a wide range of scientific and clinical evaluations, from grounded-theory, thematic and phenomenological hypotheses to define post-market clinical follow-up and related studies. We also support these activities by improving manufacture’s clinical evaluation processes and procedures. Where instructed, our Clinical Trial Program completes the full complement manufacturers might require.
QFI can also produce clinical evaluation using a client’s own templates and proformas. We are adept and lead the way in clinical evaluation according to MEDDEV and IMDRF guides, including attending to asymmetric information, device equivalence criteria development and resolving older or background medicine medical devices just as adeptly as state scientiae and leading-edge technology and treatments.
Clinical Trials Program
In order to market a medical device intended for human therapeutic use, a regulatory body requires evidence that it is both safe and effective. Clinical information is necessary to demonstrate the benefit of using a device against the risks associated with its use. A manufacturer might demonstrate safety of a device by conducting a clinical literature review for similar products but if clinical data are limited, a manufacturer must generate clinical evidence by conducting clinical investigations.
Quality First International’s Clinical Trials Program is designed to fulfil the US Food and Drug Administration, UK, European, Australian, Japanese and Canadian medical device clinical investigation requirements plus recomendations and guidelines such as ICH. Depending on our clients’ clinical needs, QFI can conduct an extensive literature review to identify relevant clinical data or manage an entirely new clinical investigation to verify the performance and safety of a specific medical device. As a Clinical Research Organisation, Quality First International manages, plans, designs and implements every aspect of the clinical trials process on behalf of our clients, working to international standards and regulations. QFI aims to ensure that our clients’ medical devices gain global regulatory acceptance and to provide quality assurance at any stage of the clinical trials process. QFI is experienced in preparing clinical trial applications for example, for:
- The US Food and Drug Administration
- Europe’s directives including the Medical Devices Directive
- The Japanese Ministry of Health and Welfare
- The Canadian Medical Devices Conformity Assessment System
QFI also accommodates WHO and other recommendations for clinical research in human subjects and has produced or helped development of ethics committees in various parts of the world.
Quality First International has extensive experience in the following:
- Submitting applications to the appropriate body
- Performing feasibility studies
- Designing clinical trial protocols
- Preparing Case Report Forms
- Investigator and site selection
- Coordinating clinical trials
- Analysing clinical data
- Outlining key results in a technical summary
- Preparing Interim and Clinical Investigation Summary reports
- Preparing final reports
- Conducting post-market studies
QFI provides independent audit of the clinical trial including investigator site audits trial master file audits and database audits.
Corporate Excellence Programme
EU Authorised Data Protection Representative Programme (EUADPRP)
- EU data protection representation services to organisations outside the EEA
- Official address as GDPR representative through our offices in the EU and UK
- Point of contact for personal data protection pursuant to the regulation
- Communication and act of on behalf with European and UK data protection supervisory authorities
- Notify and assist in resolving investigations on breach of personal data
- Where agreed, retain data protection processing activity records according to Article 5 (1) (e) Regulation (EU) 2016/679
- Conduct preliminary and renewal data protection system conformity assessment to identify areas our client members might need to improve
- Evaluate documented processes and procedures, conduct Data protection impact assessments
- Devise and implement documented systems, processes and procedures in client member management systems to integrate Regulation (EU) 2016/679, Data protection Act 2018 and Regulation (EU) 536/2014 also where requested, US Privacy Shield elements
- Conduct data protection risk assessment, formulate safety and reliability engineering analysis and cover NHS digital standards requirements
- Check if your organisation records of processing activities comply
- Examine data protection technical documentation required by Regulation (EU) 2016/679 and Data protection Act 2018 is complete
- Check procedures to fulfil data transfer requests and attend to breaches of personal data to ensure that they are compliant and efficient
A company supplying products and services to customers in the European Union that does not have an office or is not established in any EU Member State or in the United Kingdom, probably requires an EU authorised data protection representative.
QFI can serve as an EU Authorised Data Protection Representative according to Recital 80 Regulation (EU) 2016/679 and Data Protection Act 2018 (Pure and Applied GDPR) supporting medical device manufacturers who collect, process and archive personal data on European data subjects pursuant to Regulation (EU)2016/679.
Such personal data necessary in fundamental scientific research, risk assessment, clinical investigation and other health-related purposes, are subject to the Regulation.
While manufacturers are generally familiar with the requirements and recommendations concerning informed consent and other ethical committee expectations, comprehensive understanding of regulations on special categories of personal data, probabilities, requisite controls and available penalties for violation, are less known.
Our EUDPRP provides the following:
QFI offers services as designated representative according to Article 27 of the Regulation through a fully-documented EU Personal Data Protection Designated Representative Programme [EUPDPDRP] designed for the medical device sector.
Our services cover marketed product, including medical devices, personal protective equipment and related technologies such as stand-alone and cloud-based medical device software, product undergoing clinical investigation or supplied for special purposes, as well as digital systems supporting medical use.
Additionally, QFI will continue to offer data protection representation into the UK beyond 31 December 2020.
EUDRP acts on behalf of a data controller on processor pursuant to Chapter IV Section 1 Article 27 Regulation (EU) 2016/679, including obligations where Article 3 (2) apply to Representatives of controllers or processors not established in the Union.
The programme also offers practical resources to help manufacturers conduct personal data protection regulation gap analyses, assess risk, produce documented procedures integrated within registered QMS and other management system constructs, evaluate concordance of international arrangements to avoid violation of European requirements and, where necessary, help remediate breaches of personal data obligations involving medical devices, thereby improving security and safety measures.
At QFI, we:
If data protection professional consulting services are required, we can provide GDPR compliance inspections and audits, devise and assist implementing compliance management systems and solutions, create data protection governance programmes, create privacy policies and deliver specific training.
Expert Witness Programme
QFI offers an unbiased Expert Witness service in support of:
- Independent Review
- Analytical Investigation
- Low and High court actions
Our specific areas of expertise include:
- A wide range of medical devices, especially high-risk, orthopaedic, cardiology, radiology, biomaterials, permanent implants, infusion & transfusion, medical electronics, active implantable devices, drug device combinations, in vitro diagnostic products, animal tissue derived products and borderline devices
- Alleged breaches of the General product liability Directive and related Transposition in particular EU Member States, including alleged negligence
- Investigation of alleged device failure and malfunction
- Medical device toxicology
- Alleged device misuse
- Sterilisation and microbiology
- Medical device intellectual property assessment
Our Experts are registered with the Expert Witness Institute and other professional bodies and have participated in a variety of medico-legal, civil and criminal settings.
Labour Standards Assurance System Programme
Medical Device Business Segment services
Medical Device Environmental Waste Management Programme
QFI’s environmental waste management system unites global and sectorial legislation, initiative, policies and standards in a seamless, integrated programme to assist manufacturers and other economic operators who design, manufacture, distribute and maintain medical devices in fulfilling environmental targets.
Considerably beyond superficial, EMS-type audits, we are adept in transforming environmental factors into effective, documented systems equipped to ensure our clients produce optimally- environment friendly devices and services. Competence in requisite regulatory and technical areas, complemented by scientific professionals in medical device technology, we can conduct environmental regulatory and management system impact assessments, formulate environmental risk policies, assess risk thereof and guide companies seeking improvements in environmental compliance.
Our specialists can help investigate environmental excursion and out-of-specification conditions, advise remedies and recommend solutions, along with create compliant environmental management systems, including ISO 14001 and other goal-oriented standards.
- Leadership in medical device industry and medical device quality through accountability and engagement of different stakeholders,
- Broad and improved awareness and communication on environmental issues,
- Strategic business approach for enhanced environmental performance,
- Production of high-performing environmentally-healthy products,
- Compliance beyond existent practices,
- Meeting increasing stakeholders’ expectations and demand for sustainable products,
- Improved reputation and competitiveness, which attracts investors and other markets,
- Enhanced business profitability.
Medical device risk assessment
Microbiology Advisory Program
Development of an effective contamination control system is essential in aseptic, terminally sterilised and non-sterile medical device manufacture also many re-useable devices requiring reprocess before continued use constituting a critical factor in qualification and subsequent control of product to ensure safety, quality and performance.
QFI has extensive experience in laboratory testing, residual testing, disinfection studies, biological safety and cleaning, disinfection and sterilisation. The Microbiology Advisory Program (MAP) provides all the benefits you would expect from Europe’s leading consultancy, ensuring that you can demonstrate that your microbiological contamination level is documented, trended and appropriately controlled and fulfils the appropriate regulatory requirements.
QFI’s specialists can help in the following key areas:
- determining microbiological requirements for placement of medical devices on the market
- advice, organisation and co-ordination of sterilisation validation and routine cycles
- specialist protocol and report preparation and review
- defining controls for product release
- developing practical, cost-effective testing
- defining controls for hygiene and environmental control
- preparation of procedures
- regulatory support, including conformity and microbiological risk assessment
- on-site attendance and support during customer, Notified Body, MDSAP, MHRA and FDA audits and inspections
- vendor and sub-contractor audits
Additionally, QFI advises on clean room cleaning practices, selection and qualification of cleaning agents and methods, investigation of episodes of contamination and related hygiene matters.
QFI can assist in development of cleaning, disinfection and sterilisation methods, evaluation of materials and techniques, investigates excursions also design validations. Our specialists have lengthy, successful practical experience in producing sterilisation protocols, assessing compliance of sterilisation cycles and operations and much more.
QFI is one of only few consulting specialists able to perform detailed microbiological risk analysis on medical devices and operations. We can also help devise Formal systems.
Product complaint handling Services
QFI offers a wide-range of market surveillance and product complaint handling services. For manufacturers and other medical device economic operators seeking supplementary professional technical support to assist processing and investigating complaints, produce reports or specific topical assistance, we can quickly, efficiently and seamlessly augment complaint and field action resources. Our technical specialists possess direct, hands-on practical experience of dealing with product complaints, having prior roles at Competent authorities or other regulatory agencies also at leading medical device manufacturers.
We also help in cases of unrealistic/ zealous product complaint process remediation, where we can eliminate unnecessary work manufacturers are frequently mal-advised to embark on, devise efficient procedures fulfilling global medical regulations and applicable standards.
QFI can analyse:
- complaints properly
- produce market surveillance and periodic reports
- ensure proper feedback to risk management and remediation initiatives
- ensuring otherwise un-contained CAPA fixes are not mistakenly applied instead of achievable/ practicable compliant solutions
Registar* – Medical Device Registration
Registar* is the programme from Quality First International that registers medical devices with any country in the world. QFI identifies and applies specific pre- and post-market medical device registration requirements and prepares summaries or detailed medical device registration submissions. Registar* offers individual low-cost reports that offer guidance through each country’s medical device registration requirements. Alternatively, Registar* completely manages the entire registration process of a medical device to any country.
Medical device registration is a significant issue when marketing in Europe. The Directives transposed into national laws, whereby each EU Member State has written the mandatory use of its own language for the information on the product and/or labelling for example, according to paragraph 13 of Annex I to Council Directive 93/42/EEC, means that some EU Member States operate distinct registration scheme of medical devices in order to control medical devices on the market.
Service Level 1: Country Registration Overview
For each country of interest this service provides:
- a Country Registration Summary Report
- a comprehensive review of country medical device registration regulations
- the language requirements for all documentation required for medical device registration
- application forms and other associated documentation
Service Level 2: Full Registration Management
For each medical device undergoing registration, this service provides:
- a device registration device Action Plan
- a detailed Registration Report for the registration of the device in the desired country
- full submission of all application forms and corresponding documentation
- complete management of the registration of the medical device
- translation services
Every medical device manufacturer regardless of company size or the sophistication of their product will at some point find themselves out of compliance with some regulation. It may be their own standards and specification, other internal compliance requirements or regulatory infractions including FDA Form 483’s, Warning letters, Corporate Integrity Agreements, Conformity Assessment, enforcement action and decrees, QSR, ISO 9000 | 13485, etc. Whether you are manufacturing and marketing in just one country or region or involved in multi-national manufacturing and marketing, it can require knowledge of and compliance with hundreds or even thousands of regulations and standards.
Remediation to recover full compliance requires a documented plan of action. Non compliances and violations may be isolated incidents or may be systemic failures. Either way manufacturers need to: understand cause(s), examine control systems that may have failed, review potential vendor/raw material/ subcontractor issues and establish a plan that will not only resolve the particular incident but establish corrective and preventive actions. In this process, knowledge of all regulations and standards for all countries where a medical device is marketed is crucial to ensure a remediation plan will be successful and continue to work for the long term.
Quality First International has designed and led remediation programmes for companies ranging from very small to multi-national blue-chip corporations. Our knowledge of medical devices, how they function, how they are used, manufacturing processes and raw materials, vendor and subcontractor requirements as well as the regulations and requirements of all major countries make us the ideal partner to assist in your remediation programme. We also have significant experience communicating and negotiating with regulatory agencies and can act as your liaison or advisor in all such interactions and communication.
QFI remediation support includes:
- Design, implement and manage remediation and compliance programmes to bring you into full compliance
- Analysis and response to FDA Form 483 observations, Warning Letters, EU Conformity Assessment enforcement and other compliance citations.
- Navigating the FDA regulatory process to assure you meet all requirements for product clearance and approval
- Formulating timelines meeting agency expectations & help implement improvements ensuring total compliance
- Design and supervise development of systems and processes to control, manage or remediate violations
- Serving as interim regulatory staff and/or Compliance Officer.
- Serving as independent review organization (IRO) to:
- Evaluate compliance programmes
- Develop effective code of ethics & compliance programmes
- Act as internal monitor, develop monitorship work plans to assure long-term and continued compliance
- Analyse corporate culture related to quality & compliance and assist in the culture change process
- Assist with creation and implementation of corporate Integrity Agreements
- Technical-level support for remediation and litigation projects, including remediation system design, determination of regulatory applicability and conduct of feasibility or cost-benefit studies
- Examination of problem origin including thorough analysis of non-conformity, identify required actions, plan and manage a corrective and preventive action program
- Identification of potential business improvements
- Assistance in establishing and maintaining credibility with customer base as well regulatory agencies
- Coordination of on-site activities for clean-up of remediation projects to ensure compliance with laws, regulations, standards or other requirements
- Inspection of sites including suppliers and subcontractors to assess requirements or monitor clean- up progress
- Training of on site staff including management as well as suppliers and subcontractors on operations and maintenance of remediation system
Scientific and clinical literature services
QFI is a leading provider of scientific and clinical literature research on medical devices. We produce high-calibre grounded-theory, thematic and phenomenological publication quality clinical evaluations designed to fulfil medical devices clinical data by literature search and critical examination.
Whether using available clinical evaluation templates belonging to your organisation or producing our own, expert report, we are adept in fast, term-key results complying with various medical legislation. Notably, QFI produces clinical data by literature search according to Council Directive 93/42/EEC and MEDDEV 2.7/1 revision 4 and Regulation (EU) 2017/745, however, we also produce such research on active implantable medical devices and performance evaluation research on in vitro diagnostic devices.
Our technical specialists search literature databases a client specifies and uses. Alternatively, we utilise and exploit from approximately 40 databases and research libraries.
Depending on precise client requirements, QFI also produces:
- Clinical evaluation plans
- Overall medical device clinical strategies
- Clinical regulatory plans
- Clinical development plans
- Literature search protocols
- Clinical evaluation appraisal plans
- Clinical evaluation assessment plans
plus a range of protocols, eg:
leading to final evaluation reports, executive summaries and as required, presentations and posters.
Where instructed, we are able to determine conformity with mandatory and variable essential requirements/ general safety and performance requirements requiring clinical evidence of clinical safety and performance.
QFI offers a unique Standards update and review service for medical devices through our StandardsSearch Programme that ensures rigorous and accurate conformity to Standards is achievable.
Different service levels are offered as discrete packages depending on the depth and breadth each standard is applied by a Manufacturer, allowing concentration of effort where it is required.
Among the services offered are:
- Detailed Standard Applicability Report analysing (clause-by-clause application, where necessary) compliance or Conformity which recognises Consensus Standard Requirements/Article 5 1. Council Directives 93/42/EEC; 90/385/EEC; 98/79/EC (as relevant) (for the latter, Common Technical Specifications); Regulations (EU) 2017/745 and (EU) 2017/746 (as relevant) (for the later, Common Technical Specifications); CMDCAS; TGA or other schemes as appropriate
- List of Standards / Special Controls with headline changes
- Applicable Standards Update List
The StandardsSearch Programme consists of an annual StandardsSearch membership fee per product/homologous product group or generic product group covering the following:
- Review of Standards Search form listing Standards applied or application desired, submitted by the client
- Initial examination and review of technical documents submitted supporting application of Standards
- Registration of technical documents in the database
- Correlation of Standards expected to be known to the Manufacturer for each product group
- Detailed Standards Applicability Report
Usability and human factors engineering
Innovations or added capacity of a medical device or medical device system to provide conditions for users to use the device safely, effectively and efficiently, especially if operated in conjunction or simultaneously with another medical device or technology, however, must fulfil defined ergonomics, usability and human factors engineering principles.
Parameters to identify suitable options to improve medical device usability, performance and safety require careful thought, including, for example, software enhancements not for safety purposes, security patches or simply to improve operating efficiency. Inadequately-defined usability can lead to use-errors or un-ergonomic products. For these reasons-among others-medical device design must include requirements on ergonomic features, use environment, physical properties and characteristics along with user interfaces, displays plus delivery on information essential for a user to be able to use the device such that it can achieve performances intended under conditions of use specified by the manufacturer.
QFI has long experience of assisting medical device manufacturers in the field of usability and human factors engineering. Our specialists can produce full usability engineering documentation to fulfil leading international standards. For instance, we compile usability engineering documents to fulfil expectations of IEC 62366 series standards. Where required, we construct and co-ordinate usability surveys, studies and questionnaires for our clients.
QFI‘s services can help in this area from earliest design phases to post-market initiatives. Where necessary, we can define usability criteria to include in post-market studies, too.