Medical Device Environmental Waste Management Programme

2 April 2020

QFI is adept in transforming environmental factors into effective, documented systems equipped to ensure our clients produce optimally environment-friendly devices and services. The work we undertake far exceeds superficial EMS-type audits.

QFI’s environmental waste management system unites global and sectoral legislation, initiatives, 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.

With our competence in requisite regulatory and technical areas complemented by scientific professionals in medical device technology, we evaluate environmental regulatory and standards compliance applicable to the medical device industry. We also conduct environmental risk and management system impact assessments, formulate environmental policies, procedures and practices unique to each client and thereof guide your company towards continuous improvement in environmental sustainability. Our programme, ideas and imaged medical device environmental impact management criteria are un-paralleled and are not simply re-workings of conventional ISO 14001 systems. Applying QFI proven methodology, we devise means to achieve greater environmental aspirations and attributions.

Our specialists can help investigate environmental excursions 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.

Who should use this programme?
QFI’s environmental programme is suitable for medical device companies who want to:

  • achieve optimally environment-friendly medical devices,
  • improve brand value, reputation and competitive advantage,
  • reconfigure and adapt their business to remain profitable in the long term,
  • attract investors and other markets,
  • demonstrate superior responsibility for environmental impacts from business operations,
  • improve risk management and environmental legal compliance,
  • gain leadership through accountability and engagement of different stakeholders,
  • create a culture of continual improvement of business processes towards environmental sustainability.

What will I gain from this programme?
QFI’s environmental programme will help you to achieve:

  • improved technological and organisational strategy,
  • comprehensive understanding of business processes’ environmental risk and impact complexity,
  • unique strategic business plans and techniques geared towards environmental sustainability,
  • enhanced environmental performance and compliance with environmental legislation,
  • compliance beyond existing practices,
  • production of high-performing, environmentally-friendly products,
  • increased stakeholder expectations and demand for sustainable products,
  • improved reputation, competitiveness, and potential opportunities in business development,
  • comprehensive awareness and effective communication on environmental issues,
  • improved environmental sustainability in organisational culture and functionality,
  • enhanced business profitability.

Microbiology Advisory Program

2 April 2020

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

2 April 2020

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

11 August 2020

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

Remedium Programme

2 April 2020

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

2 April 2020

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
      • plus a range of protocols, eg:

        • Literature search protocols
          • and

            • Clinical evaluation appraisal plans
            • Clinical evaluation assessment plans
              • 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.

StandardSearch Programme

2 April 2020

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 – MEDICAL DEVICES

2 April 2020

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.

Medical devices generally possess inherent or intuitive usability, properties and characteristics typically originating at manifestations known or believed typical or ideal.

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.

Medical device design must include requirements on ergonomic features, use environment, physical properties and characteristics along with user interfaces, displays plus delivery of 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‘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.