Biological Safety Programme

2 April 2020

QFI’s Biological Safety Programme evaluates composition of raw materials, intermediate and finished products ranging from permanent implants, intravascular catheters, permanent cardiac implants, left ventricular assist devices (PMA), plus lesser devices to determine whether anticipated intolerance by the body can be predicted. Success will depend on availability, depth and currency of prevailing, promulgated information, including reliance on reference (State-of-the-Art) devices such as 510(k) premarket authorisation:

  • 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

2 April 2020

QFI launched the first specially-devised and dedicated Brexit medical device support service, to prepare manufacturer’s and other medical device economic operations for Exit day, thereby avoiding disruption to marketing in the United Kingdom as well as the remaining EU Member States.

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

2 April 2020

CE-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 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

2 April 2020

QFI specialises in devising and producing high-calibre clinical data to fulfil European and other medical device legislation. Our clinical evaluation programme offers full package of evidence to fulfil Regulation (EU) 2017/745 as well as Council Directives 90/385/EEC and 93/42/EEC.

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

20 February 2020

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.

EU Authorised Data Protection Representative Programme (EUADPRP)

2 April 2020

    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:

  • 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
  • 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:

  • Ensure your privacy policy, data protection processes and procedures fulfil 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
  • 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

2 April 2020

QFI offers an unbiased Expert Witness service in support of:

  • Defence/Prosecution
  • Independent Review
  • Criminal/Civil
  • Analytical Investigation
  • Liability/Negligence/Mitigation
  • 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.