Short Presentation

Ann-Helen Engman

Owner and Senior RA QA Consultant

Senior RA/QA Consultant with long experience from both large global companies to smaller companies, holding various positions within RA/QA from Specialist to Global Senior Vice President. 

Started MIQARA Consulting AB in 2023.

Lead auditor of ISO 13485, ISO 9001 and ISO 14001.

Involved in standardisation development work within ISO since 2008, such as ISO 13485, ISO 14971 and IEC 62366-1.

Experience of medical devices, IVD, combination products, custom made products, including SaMD/SiMD and HW.
Experience of non-medical device process and lab equipment as well.

Support with interpreting regulatory texts like legislations, MDCG guidelines, other guidelines as well as standards.

Experience from implementing the new regulations (MDR/IVDR) and responsibility for ISO 13485/ISO 9001 Quality Management Systems and ISO 27001 Information Security Management System.

Experience from various submission files.

Work in a structured way, oriented both strategically and detailed.

MIQARA Consulting AB
Contact: Use the contact form or call mobile +46 (0)767234985

EDUCATION
Royal Institute of Technology, Stockholm
MSc Chem Eng
1987-1991

IHM Business School, Stockholm
DIHM Marketing, prize for best Thesis
1999-2001

RAPS
Regulatory Affairs Certificate:

Medical Devices and Pharmaceuticals (Dual)
2012

SKILLS
MDR, IVDR, Technical Documentation files, CE marking, FDA, 21CFR820, 510 (k), Design Controls, Risk Management, Quality Management Systems, Auditing, Machinery Directive, Low Voltage Directive, EMC Directive, RED, RoHS, REACH and other international legislations. Leadership and Executive board.
Medical devices, In-vitro diagnostics, combination products, custom-made products, SaMD, SiMD, SW, HW, non-medical devices.

LANGUAGE
Swedish - fluent
English - excellent
German and Spanish – working knowledge

Full CV available upon request