Quality Assurance and Regulatory Affairs

ID1025

Senior Consultant Audit and Validation

B.Sc. Business
Available for: Tasks

Competences

  • Qualified Lead auditor with notified body experience for:
    • Medical Device Regulation 2017/745 (MDR).
    • MDSAP.
    • Medical Device Directive 93/42/EEC.
    • ISO 13485:2016.
    • ISO 9001:2015.
  • 3 years of international audit experience within Quality Management Systems.
  • Expert in process validation

Key results

  • Conducted +100 international MDSAP/ISO 13485/CE audits for notified body and accredited organization.
  • Key responsible for validation activities (process and software) for international FDA compliance projects.

Regulations/Standards/Guidance

  • Medical Device Directive MDD 93/42/EEC.
  • Medical Device Regulation MDR2017/745.
  • ISO 13485:2016.
  • ISO 9001:2015.
  • MDSAP.
  • Harmonized/Internationally recognized standards i.e. ISO13485, ISO14971, EN62366, EN62304.
  • MEDDEV 2.7.1/4

Extensive knowledge in:

  • MDD 93/42/EC.
  • ISO13485:2016.
  • FDA regulation [CFR part 820].
  • MDSAP.

Personal Characteristics

He is a thorough and dedicated person, who believes that results are best achieved in a straight forward open minded dialogue between the parties.

His spare time is used watching films, theater, football or art exhibitions.
What time is left is allocated for music, food, books and traveling.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com