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Achievements


Obtained CE marking for 4 class IIb sterile devices

Obtained a products range extension for a set of CE marked class IIb devices

Obtained FDA clearance for a range extension for Class II medical devices in the US through a 510(k) process

Obtained ISO 13485:2016 certification for a subcontractor producing injected plastic parts for medical devices

Obtained ISO 13485:2016 combined with ISO 9001:2015 certification for a provider of sterilization validation services

Successfully passed (few observations each time) more than two dozens (re)certification audits and follow-up audits by European notified bodies and by the FDA for different medical devices manufacturers

Set-up the technical file for 4 class I & 1 class IIa active devices

Documented the development of more than a dozen class I and class IIb devices within an ISO 13485 quality management system and updated the technical file covering a range of products to include the new devices

Provided most of the quality management system for a class III devices manufacturer and for a class I active devices manufacturer

Revalidated a dozen of steam sterilization cycles for class III terminally sterilized devices and validated a recommended steam sterilization cycle for resterilizable class I and class IIb devices

Completed the validation of the final stage cleaning, packaging, and EtO sterilization for class IIb sterile medical devices

Set-up of a partial quality management system (as per Annex V of Directive 93/42/EEC) for a class IIb devices manufacturer


Performed a gap analysis on more than a dozen of technical files for class I and class IIa devices (including in-vitro diagnostic devices), and of 1 active implantable device

Developed, finalized and/or updated, in all cases reaching compliance with the EN ISO 14971 standard, the risk management file of more than half a dozen devices of different classes (including active devices)


Developed the usability engineering file for 5 ranges of medical devices (classes I and IIb, and active class I devices)

Rebuilt the suppliers management process and files for a class I and class IIb devices manufacturer

Managed the development and produced the technical transfer file for a class III combination device (that reached pre-clinical R&D step)

Performed a technical review of active implantable medical devices as part of a reinbursement file of an active implantable medical device


Assignments


Quality & regulatory manager (part-time) for an ISO 13485 certified, class I and IIb devices manufacturer

Supporting two dental medical devices manufacturers for their quality system and products certifications

Led 8 Internal audits over 5 years for a class III devices manufacturer

Quality & regulatory manager (part-time) for an ISO 13485 certified, class I devices manufacturer

Quality manager ad interim (5 months, part-time) for a class III devices manufacturer

Training on technical file contents and maintenance, and on risk management file contents and update to a class I and class IIa devices manufacturer

Lecture on introduction to quality management in regulated industries for engineering students

Support to the quality manager of a supplier of parts for medical devices during the finalization of the transition from its sole ISO 9001 certification to the ISO 13485 compliance and certification