We are truly experts in Class I, II and III devices and serve a range of clients from small startups to large Medical Device Companies. CMSI is an FDA, ISO 13485 and ISO 9001 registered medical device manufacturing firm offering comprehensive manufacturing services. CMSI can offer the assistance your company needs to get your medical device to the market. We have all the necessary resources in place working in harmony to accomplish this task. Our departments each contribute their own varied expertise including FDA & ISO compliance in regulatory and quality systems, auditing, submissions, software development, software verification & validation, software quality assurance, risk/hazard management, design control, biocompatibility, electrical safety, etc.

Many companies have the technical expertise to assemble their scientific information for a 510(k) submission, however require assistance with the format and verification. There is no question that preparing the necessary documentation for FDA device approval can be a complex process that can take time away from an enterprise's focus and resources. CMSI can simplify and accelerate what can otherwise be a lengthy and puzzling process.

CMSI’s astute team possess the knowledge and expertise to know clearly what the FDA wants to see in each application and what to refrain from. There is not a 510(k) application template or very much information explaining what needs to be included in each section of the 510(k), it is rather ambiguous. Many who try to complete the application find the process more daunting than they expected, resulting in significant delays in getting their product cleared for sale.

Our team will perform a gap analysis and furnish a comprehensive document identifying exactly what information will be required for preparation of the 510(k). Once the gaps are identified, CMSI can assist in the efforts of fulfilling the areas lacking and upon completion will prepare the 510(k) submission. The preparation entails preparing the 21 sections of the application in their entirety, submitting the 510(k) to the FDA and be accessible to clarify any questions from the FDA reviewer. CMSI is committed to it’s customers in every way and is always looking for another solution to help avoid our customers from having to deal with multiple companies, we can essentially aid in all steps required to product production.