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Achievements


Obtained CE marking for 5 class IIb sterile devices (and updates of the whole technical file, including risk management, biological evaluation, usability engineering, information to be provided by the manufacturer, ...)

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 providing injected plastic parts for medical devices

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

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

Set-up the whole technical file for 6 class I devices & 1 class IIa active device

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

Created the biological evaluation protocol for a class III, a class IIa and three class Ir devices

Provided support to the QA department of two subcontractors of surface treatments for medical devices


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)

Rebaked the quality management system for the 2016 revision of the ISO 13485:2016 for 3 medical devices manufacturers (of class IIb and class I devices), including clean room manufacturing management

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


Developed the approach to product cleanliness requirements for a whole range of dental devices

Performed and internal audit relative to the CH-Rep requirements


Assignments


Performing the tasks of the quality & regulatory manager (part-time) for several ISO 13485 certified, classes I to III devices manufacturers and medical devices subcontractors

Supporting three dental medical devices manufacturers for their quality system and products (instruments and implants) certifications

Led 2 dozens of complete or partial internal audits for class III devices and active implantable devices manufacturers

Given trainings 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