QMS & Medical Device Certification
Medical Devices are highly regulated products & different countries have a different regulatory approach(for that we need different medical device certification) for market clearance & sale of medical devices. Medical device varies in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software. When a manufacturer decides to enter a new market, he has to consider not only the regulatory requirements of that particular market but also has to determine how those requirements apply to his product.
Get Register QMS & Regulatory Certification For Your Medical Device
The Efforts of Operon Strategist in helping us resolve our various regulatory queries have been outstanding. Their expertise & regulatory knowledge puts them on par with other globally recognized regulatory consultants.
We hired Operon consultant as a subject matter expert for overseeing sterilization activity by adhering to the protocol and for reviewing results and reports in line with global standards and our requirements for the commercial launch of a product in the global market. The team exceeded our expectations by providing quality outcome and played a vital role to launch the product in time.