FDA Regulatory and Clinical Services for the Medical Technology Industry

Services: FDA Regulatory Consulting

We take care to understand each client's US and global business objectives to assure that the regulatory strategy complements and supports plans for commercialization. In addition to preparing 510(k)s, IDEs, and PMAs and assuring FDA clearance or approval, we have successfully submitted a number of de novo petitions (de novo 510(k)s), we have contributed to both industry-sponsored and FDA-sponsored reclassification petitions, and we have taken a number of products through the Humanitarian Device Exemption (HDE) process.

FDA Regulatory Services offered by M Squared Associates include: