During design and development stage of the medical device, we assist various medical device manufacturers to meet regulatory compliances of the medical device design and development.Our Company Provides Medical Device Manufacturing Unit Design Consulting Services In USA, Dubai, South Africa, New York, Qatar, Algeria, Libya, Shri Lanka, Australia, Mauritius.Services In Australia, Brazil, Bangladesh, Comoros, Costa Rica, Canada, Central Asia, Colombia, Egypt, Iceland, India, Indonesia , Nigeria , New Zealand , Oman , Peru , Qatar , Israel , European Union , Europe & Middle East , Hong Kong , Kenya , Korea , Kuwait , Liberia , Malaysia , Mexico , Mauritius , Saudi Arabia , Singapore , South & Central Asia , South Africa ,Southeast Asia & Pacific , Sri Lanka , Switzerland , Russia , Singapore , Turkey , Thailand , Ukraine , United Arab Emirates.
We also help the manufacturers establish various design & development documents as required by the regulators. Design and development failure in any product is a major non-compliance & may result in 21 CFR part 820 Design Control adverse events affecting users.
We are the leading technology consultant and regulatory advisory service provider for manufacturing Set Up Design Service. Operon Strategist offer the expertise to help you set up new manufacturing unite as well as regulatory support to your facility and product.
Manufacturing Plant Design Consulting Services For Orthopedic implant Manufacturing Industry, surgical instrument manufacturing, dental instrument manufacturing Industry, implant-manufacturing, implantable-moulding, instrument-manufacturing, endodontic-instrument, diagnostic-instrument manufacturing Industry, equipment manufacturing, sterilizers manufacturing, syringe manufacturing, Disposable Plastic Syringes
During design and development stage of the Medical device design, we assist various Medical device manufacturing industries to ensure that appropriate steps are taken to meet regulatory compliances of the Medical device design and development.
In particular, we help clients meet the requirements of US FDA design controls under 21 CFR Part 820. Services meeting demands of clients looking for expanding their business, reduce bottlenecks and manufacture new products.