Get the technical file wrong, and the cost isn’t rework. It’s the launch date.

Regulatory Affairs Consulting

We write, review and remediate medical device technical documentation, across all technical areas, and answer notified body deficiencies from an ex-assessor's perspective.

We have experience with all aspects of regulatory submissions for implantable, non-implantable and surgical devices, from labelling and IFU, through design control, risk management, verification & validation, packaging validation, transit validation, shelf life validation, biological safety, and clinical evaluation.

Our experience is second-to-none for EU and UK submissions, but the same principles and standards also underlie most international regulations.

  • Under the new EU Regulations, Notified Bodies have come under pressure to demonstrate impartiality by limiting how many technical questions they can ask.

    To limit administrative questions during technical documentation audits, they conduct a screening step (the completeness check).

    Notified Bodies publish guidance for the format and structure that they expect - check their website.

  • The MDR technical file is the aggregation of all disciplines’ work in demonstrating the quality and function of the medical device.

    This includes: A summary document, labelling and instructions for use, design control documentation (per ISO 13485), risk management documentation (per ISO 14971), verification & validation protocols and reports, biological safety evaluation, clinical evaluation plan and report, and a declaration of conformity.

  • If you need a second pair of eyes on your technical documentation before submission, we can conduct a thorough gap assessment.

    Notified Bodies have to remain impartial, and cannot recommend routes to compliance - but we can.

    Our experience is informed by working with a leading notified body, and therefore know what questions they will ask; but crucially, we can also recommend the solution.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

DIRECTOR

Bio

The technical file is how you converse with the notified body. It should tell the story of your device, from concept through any design and manufacturing changes.

Every engagement is unique, and we tailor a bespoke set of deliverables to every project.

Services

TECHNICAL DOCUMENTATION WE CAN WRITE, REVIEW OR ADVISE ON:

  • Technical documentation summary

  • Qualification as a medical device

  • Classification rationale

  • GSPR checklist

  • Harmonised & relevant standards

  • Labelling and symbols

  • Instructions for use (IFU)

  • Implant cards & information for patient

  • Electronic instructions for use (eIFU)

  • Packaging - sealing validation protocols and reports

  • Shelf life testing protocols and reports (device and packaging)

  • Transit testing protocols and reports (devices and packaging)

  • Biological evaluation protocols and reports

  • GSPR 10.4 justifications (CMR and Endocrine Disrupting substances)

  • Clinical evaluation

  • Declarations of conformity

  • Design control

  • Design verification & validation planning

  • Manufacturing information - process flows, specifications, inspections and controls

  • Process validation protocols and reports

  • Critical subcontractors and crucial suppliers

  • Risk management files, including risk analysis (e.g. FMEA) and benefit-risk determination

  • Performance testing protocols and reports

SEE MORE ABOUT:

Electronic IFU
Clinical Evaluation 
For a More Prepared Future

  • EU MDR

  • ISO 14971 Risk Management

  • Technical documentation best practices

Training

  • Full new product development process flow evaluation

  • Quality & regulatory career paths and training plans

Management Consulting

  • A GSPR checklist is how we comply with Part 4 of EU MDR Annex II (or EU IVDR Annex II).

    In the checklist, you must identify:

    • If a GSPR is applicable to your device

    • Where a GSPR does not apply, a rationale

    • Reference to Common Specifications, Harmonised Standards, or other standards used to demonstrate conformity

    • The precise identity of the controlled documents offering evidence of conformity

    Auditors will often use this as a starting point. For example, if they are interested in the shelf life validation for your device, they will start at GSPR 7 (MDR), and follow references to your documentation.

  • For medical devices under EU MDR, a CER is always required.

    Similarly, for in-vitro diagnostic devices under EU IVDR, a performance evaluation report (PER) is always required.

    Both legislations have a concept of the level of clinical evidence required to demonstrate conformity. Some devices might be extremely simple, represent a long term stable standard of care, and be low risk. Those devices still need a CER or PER, but the manufacturer can justify why the required level of clinical evidence is lower.

  • Yes! There is no requirement that you have to write your technical documentation in house. What you should do is verify that any external parties have appropriate competence for the activity that they are performing. We are happy to provide our credentials for these projects.

Need some support with technical documentation?

Enquiries

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