FDA Regulatory Pathways and Submission Types Some of the pathways to market you may not have heard much about. Special 510(K) Traditional 510(k) Abbreviated 510(k) PMA and PMA supplements HDE/HUD De Novo Combination Product – Read more in SPECIALTY SERVICES Investigational Device studies may... Read more »
Design Control Reduce costs and time to market with efficient development systems All successful regulatory submissions are supported by FDA compliant Design Control and Review systems. Quality System Regulations (21 CFR 820 :QSRs) and ISO 13485 require documented design review according to... Read more »
Qualification Planning and Testing requires coordination of the development of protocols with product claims, risk mitigation and performance requirements. Qualification planning pulls together Design Control compliance, regulatory submission requirements, such as development of claims,... Read more »
Cleanroom Consulting, LLC, specializes in cleanroom design and applications, cGMP cleanroom compliance, contamination control and FOD consultation, cleanroom and contamination control audits, and new cleanroom product introductions. Read More
BioFit manufactures ergonomic seating, cafeteria and mobile folding tables and carts for educational settings. All BioFit seating products are LEED® compliant and our tables are GREENGUARD® Gold certified, reinforcing our commitment to the welfare of our customers and the environment. Read More
