Quality system and regulatory services
Two distinct areas, presented separately so you know exactly what each engagement covers, plus support for MedTech start-ups that draws on both.
Quality management system
ISO 13485:2016
A quality management system must meet the standard’s requirements without weighing down the way the company operates. I help set it up, take it over or run it, and prepare for audits.
Clients
- Manufacturersfrom Class I to Class III
- MedTech start-upsa QMS proportionate to the project’s stage
- Importers and distributorschecks, traceability, complaints and vigilance
What the service covers
- QMS implementation and management
- Processes, responsibilities, management review and indicators, in line with ISO 13485:2016.
- CAPA
- Handling nonconformities, root cause analysis, corrective and preventive actions, effectiveness checks.
- Change control
- Assessing the impact of a product or process change, including its regulatory impact, before it is implemented.
- Document management
- Document architecture, control of records, setting up or taking over an electronic document management system.
- Internal and external audits
- Planning and conducting internal audits, preparing for external audits, following up findings.
- Complaints and vigilance
- Complaint handling, incident analysis and materiovigilance reporting.
- Notified bodies and competent authorities
- Preparing exchanges, responding to requests, following up commitments made.
Typical situations
- A first ISO 13485 certification to obtain
- A certification or surveillance audit to prepare
- Findings to close following an audit
- A quality system that has become too heavy and needs simplifying
Regulatory affairs and CE marking
Regulation (EU) 2017/745
The European regulation sets the conditions for placing medical devices on the market. I work on the entire file, from device design to post-market surveillance.
Clients
- Manufacturerscompliance and technical documentation, from Class I to Class III
- MedTech start-upsCE marking strategy and file built as development progresses
- Importers and distributorsverifying the conformity of devices made available
What the service covers
- Regulation (EU) 2017/745
- Identifying applicable requirements, classifying the device, compliance plan.
- Design file
- Design inputs, verification and validation, risk management under ISO 14971.
- Technical documentation
- Compiling, updating and reviewing technical documentation (Annexes II and III of the regulation).
- Post-market surveillance
- PMS plan, collection and analysis of field data, related reports.
- Clinical evaluation
- Managing the clinical evaluation plan (CEP) and report (CER).
- Biocompatibility
- Biological evaluation under ISO 10993-1: evaluation strategy and analysis of results.
- Sterilisation validation
- Gamma irradiation and ethylene oxide processes.
- Packaging
- Validating packaging and its ability to protect the device until it is used.
Typical situations
- A first CE marking
- Transitioning a device certified under the former directive to Regulation 2017/745
- Technical documentation to complete following notified body comments
- A change of material, sterilisation or packaging on a marketed device
From Class I to Class III
The regulation classifies medical devices according to their level of risk. The higher the class, the greater the evidence required and the involvement of the notified body.
My career covers the whole scale: Class I devices at GIBAUD, Class I to IIa at Tetra Médical, and Class III at Cardial, with vascular prostheses and a surgical glue.
- Class Ilow risk
- Class IIamoderate risk
- Class IIbhigh risk
- Class IIIhighest risk
Support for MedTech start-ups
A start-up develops its device, builds its organisation and prepares for market access all at once, often with a small team. I support it on all three fronts: product development, quality system and regulatory affairs.
The aim: to produce the evidence needed for CE marking as development progresses rather than reconstructing it at the end, with a quality system proportionate to the size of the company.
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. See details
Tell me about your project-
Product development
- Structuring the design file
- Risk management under ISO 14971
- Biocompatibility, sterilisation and packaging considered from the first choices
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Quality system
- ISO 13485 QMS scaled at each stage
- Document control from the design stage
- Preparing for the certification audit
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Regulatory affairs
- Classification and regulatory strategy
- Technical documentation and clinical evaluation
- Preparing exchanges with the notified body
Diag Dispositif Médical with Bpifrance
I am listed by Bpifrance as an expert for Diag Dispositif Médical, a programme supporting innovative start-ups and SMEs through the key stages of bringing their medical device to market.
Within this programme, Bpifrance covers half the cost of the service for eligible companies. We can discuss this in our first conversation.
- Funding share
- 50%of the cost of the service covered by Bpifrance
- What the programme covers
- In particular, setting up a quality management system compliant with ISO 13485 and compiling or upgrading the technical documentation for the CE marking file.
- Who it is for
- Innovative start-ups and SMEs; the modules available depend in particular on the device class.
- Duration
- 6 to 18 months.
Eligibility criteria and detailed terms on the official programme page (in French).
How an engagement works
Each engagement is based on a proposal built around your situation: there is no standard package.
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An initial discussion
You tell me about your device, its stage of development, your deadlines and your constraints.
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A written proposal
I send you a proposal specifying the scope, the format (one-off assignment or long-term support) and the timeline.
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The engagement
I carry out the assignment and, where the project requires it, bring in complementary experts while remaining your point of contact.
Which area fits your project?
If you are not yet sure whether your needs relate to the quality system, regulatory affairs or both, that is a good starting point for an initial discussion.