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 »
International Language Services provides highly specialized document translation services for medical device, manufacturing, and industrial organizations that go far beyond the basic translation services of generalist translation firms. International Language Services provides hands-on project... Read More
mdi Consultants, Inc. is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotechnology and food companies achieve compliance with U.S., European and Canadian regulations. Read More
Navitas Clinical Research, Inc is a wholly owned subsidiary of Navitas, Inc. and stepdown subsidiary of Navitas Life Sciences Ltd. We are a full-service CRO supporting diverse clients like you with the design, execution and result analysis of their observational studies, registries and clinical... Read More