More than 60 years combined experience in the test-house, medical device and IT industry.

·      Highly proficient in Regulatory Affairs, safety standards, and the certification business supported by a commitment to develop safe and regulatory compliant medical devices.

·      Extensive experience in EU /NA , China, and Latin America Regulatory Affairs and safety standards (Risk Management, Usability, PEMS, IEC 60601 series, IEC 60950-1/IEC62368-1, and IEC 601010).

·      Participated in working groups (IEC, ISO, CEN, CENELAC, and National) writing the 3rd Edition of the IEC 60601 and other Medical Device Safety Standards

·      Interacted with Authorities, Notified Bodies, and 3rd Parties.

·      Extensive experience in Design and Engineering in the fields of Product Safety/Regulatory Compliance, electrical/electronics design 

·      Trained safety engineers worldwide (UL, CSA, JQA, KTL, etc.)and presented Safety and RA Seminars around the world

·      Expertise in supporting QS auditors in Medical Electrical Equipment issues for Quality Systems Regulation (e.g. ISO 9000, EN4600, MDD, ISO13485).

·      Supported attainment of country specific marks such as Gost/EAC (Russia) and BIS (India)

Our team is ready to guide and consultant you thru the obstacles of your journey to market access