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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 |
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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 |