GlobalMark Inc - Improving time-to-market through regulatory compliance strategies.
We have assembled a hand-picked team of consultants that are among the leading experts in their fields specializing in regulatory and compliance. From design guidance, feasibility analysis, risk assessments, international strategies, document preparation to technical files our team can efficiently guide you through the compliance process.
The balance of experience in industry as well as senior positions at certification agencies is what sets us apart. The value to our clients is that we get it right the first time to help you to build confidence in your design and compliance schedules. Our consultants have held positions at and worked with companies such as; Cisco, Rockwell Collins, GE energy and medical divisions, Emerson, DJO, Edwards Biosciences, Boston Scientific, CSA, UL and Intertek.
We will provide value to your core teams from start-ups to fortune 100 companies.
Hazardous locations – We specialize in all methods of protection for North America, ATEX and IECEx schemes. Our consultant has worked at CSA for 18 years and was their technical lead and sat on the international standards writing committee for IEC 60079.
Medical – We have 3 consultants that have specialties in various areas of quality and regulatory. From experience with Notified Bodies as a lead auditor, senior technical reviewer, FDA compliant software, VP of QA/RA, Risk management file creation for IEC60601-1 3rd Edition, successful remediation of FDA 483 and warning letters to international dossier preparation for global approvals.
EMC – 30+ years of experience working on IT, aerospace, medical, robotics and military projects with the most stringent EMC design protocols in the world. Our consultant was a Principal Technical Leader in Electrical Engineering / Technical Project Manager in the field of electrical system design, package and board level electrical design and analysis.