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MedTech start-ups: quality and regulatory from day one

Quality and regulatory affairs for medical devices

Quality engineer, then quality and regulatory director: I support start-ups and medical device manufacturers with 20 years of industry experience.

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  • Listed by BpifranceDiag Dispositif Médical · 50% covered
  • ISO 13485:2016 Lead AuditorTrained by BSI
  • A single point of contactDM-STRAT, since April 2022
  • years of experience with medical device manufacturers
  • Class I to III from wound dressings to vascular prostheses
  • Cardial · GIBAUD · Tetra Médical manufacturers where I held in-house roles

The same profession, now as an independent consultant

DM-STRAT is not a career change. I practise the same profession I did in-house, with manufacturers covering very different risk classes.

  1. Cardiala BARD subsidiary

    Process and systems quality engineer, then quality and regulatory affairs manager

    Class IIIvascular prostheses, surgical glue

  2. GIBAUDÖssur group

    Quality director

    Class I

  3. Tetra Médicalmanufacturer

    Quality and regulatory director

    Class I to IIacare kits, wound dressings, surgical drapes

  4. DM-STRATsince April 2022

    Founder, quality and regulatory affairs consultant

    Class I to IIImanufacturers, distributors, importers, start-ups

Background and training

Two areas of expertise

Quality systems and regulatory affairs are linked, but they answer different requirements. I treat them as two distinct areas, which you can call on separately or together.

Quality management system

ISO 13485:2016

Setting up, maintaining and auditing a quality management system suited to your business.

  • QMS implementation and management
  • CAPA, change control, document management
  • Internal audits, external audit preparation
  • Complaint handling and vigilance
  • Liaison with notified bodies and competent authorities
Quality system services in detail

Regulatory affairs and CE marking

Regulation (EU) 2017/745

Building and maintaining the file that allows your device onto the European market.

  • Design file and technical documentation
  • Clinical evaluation: managing the CEP and CER
  • Post-market surveillance (PMS)
  • Biocompatibility and sterilisation validation
  • Packaging
Regulatory services in detail

MedTech start-ups: quality and regulatory work is built alongside the product

For a start-up, CE marking cannot wait until the device is finished. Choices of design, materials, sterilisation or packaging have a direct impact on the technical documentation and the quality system.

I support start-ups from the earliest stages, so that these three workstreams move forward together, at a pace that suits your resources.

I am listed by Bpifrance as an expert for the Diag Dispositif Médical programme: for eligible innovative start-ups and SMEs, Bpifrance covers 50% of the cost of the service. Learn more

Tell me about your project

  • Product development

    • Design file
    • Risk management under ISO 14971
    • Biocompatibility, sterilisation, packaging

  • Quality system

    • ISO 13485 QMS scaled to your organisation
    • Document control from the design stage
    • Audit preparation

  • Regulatory affairs

    • Classification and CE marking strategy
    • Technical documentation, clinical evaluation
    • Dealings with the notified body

Who I work with

Regulatory requirements apply across the whole supply chain: I work with manufacturers as well as importers and distributors.

Manufacturers
From Class I to Class III: quality system, technical documentation, audit preparation and compliance with Regulation (EU) 2017/745.
MedTech start-ups
From device development to first CE marking, with a quality system that grows at the pace of the project.
Importers
Pre-market checks, traceability, complaint handling and vigilance.
Distributors
Checks on receipt, storage and transport conditions, reporting of complaints and incidents.

I personally lead every engagement. When a project calls for complementary skills, I bring in trusted experts and remain your point of contact.

One-off assignment or long-term support: the format is defined with you, based on your device, your deadlines and your resources.

An audit to prepare, a file to structure?

Tell me about your device and your situation. I will get back to you to arrange an initial discussion, followed by a proposal tailored to your needs.

Request an initial call melanieroulet@dm-strat.com