Jean Waldura

Jean Waldura

Medical Device Expert
Senior Consultant

Jean joined Qserve Group in January 2020 after the acquisition of Quasys Consult, the French-speaking Qserve unit.

As a senior consulting expert, he combines strong experience in design control for multidisciplinary design teams, compliance and regulations with a pragmatic, result driven approach at various levels: strategic, management, operational and execution.

The key expertise areas of Jean
  • Medical Device Regulation
  • ISO 13485:2016, ISO 14971 & ISO 19011
  • Project Planning & Managament
  • IEC6 2304 and IEC 62366
  • Software validation
  • Implementation of Risk Management Strategies
Jean about working at Qserve

"Working at Qserve is an opportunity to discover different companies active in the field of medical devices, supports and receive support for other consultants team highly skilled in the field of regulatory affairs and compliance, quality management system, auditing, clinical affairs and training".

Before Qserve

Prior to Qserve, Jean was manager Research and Development for more than 20 years at two manufacturers of medical devices.

During his first position, he was responsible for the development of active medical devices in the cardiology field. Dealing with design, development and validation of the multi-language software, including ECG and VCG automatic analysis, electrical and mechanical hardware, quality system and regulatory affairs.

During his second position he was responsible for the development and validation team in pharmaceutical trials field. He was also Project Manger for different projects. 

Learn more about our expertise within Regulatory Affairs

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