General
Ventzeslav Iordanov, the lead consultant, has more than two decades of experience in the field of complex systems architecture, of which more than 15 are in the medical device products industry. Occupying positions, varying from:
• System architect,
• Quality Engineer,
• Q&R Manager,
to:
• Head of R&D and Manufacturing, and
• Head of QA&RA
he gained extended knowledge and experience in all stages of the medical device products lifecycle.
Knowledge & Experience
In the course of these years, Ventzeslav has defined and certified several Quality Management Systems (QMS), fully compliant with the EU and US regulations. Under these QMS, he developed and certified many medical device products, including:
• Drug-device combination medical device products (class IIa),
• Electro-mechanical medical device products (class IIb),
• High-risk medical device products (class III), and
• Software medical device products (class A – C).
Education
Ventzeslav holds:
• Master of Science degree in Electronics,
• Engineer’s degree in Applied Physics,
• PhD in Electronic Instrumentation.
Additional Training
Ventzeslav has completed the following trainings and courses:
• Technical Documentation for MD Product Certification – certificate,
• Risk Analyses Medical Devices – ISO14971:2019 – 2 certificates,
• Medical Device Quality System Regulations for US – certificate,
• System Architect (8 months extended training) – 4 certificates,
• Current GMPs (Good Manufacturing Practices) – certificate,
• Business Development (1 year college training) – certificate,
• Lean Six Sigma Green Belt (3 months training) – certificate,
• Management Systems - ISO13485:2016 – certificate,
• Quality Management – ISO 9001 – certificate,
• EU Medical Devices Regulations – certificate,
• Managing Successful Projects – certificate,
• Auditing: ISO 19011 – 4 certificates,
• Basic Pharmacokinetics – certificate,
• Consulting Skills – certificate, and
• Leading to Win – certificate.