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