Regulatory affairs Suppliers Directory
Medical device regulatory affairs consultants ensure that companies follow the regulations set by FDA or other regulatory bodies around the world. They may assist with regulatory submissions, compliance, or postmarket surveillance of products, in addition to other activities. In this directory, you'll find knowledgeable regulatory affairs specialists focusing on the medical device industry.
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Gilero offers full end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries. We specialize in the areas of drug delivery, single-use medical devices, combination products, minimally invasive surgical tools and electromechanical s...
HDA Technology, Inc
--HDA Technology is a product development and contract manufacturing company that has been creating products for the world’s top medical device manufacturers for over 32 years. Since 1982, HDA has partnered with the world’s leading companies to develop and build innovat...
...companies worldwide rely on MasterControl solutions to achieve new levels of operational excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and post-market surveillance. For more information, visit ...
Noblitt & Rueland
Noblitt & Rueland, for over 25 years, has been a leading consulting and training firm to manufacturers in the medical device, pharmaceutical, and biotech industries. We specialize in technical FDA & ISO regulatory and quality issues including Quality Systems, Design Control, Risk M...
Regulatory Specialists, Inc
Regulatory Specialists Inc. is a team of skilled FDA and international medical regulatory consultants in the medical device, diagnostic, and pharmaceutical fields. Started in 1989, the company helps assure its clients' compliance with FDA, ISO, and international requirements. Due t...
Business & Decision Life Sciences
...& Decision Life Sciences provides consulting services in the fields of clinical data management, device safety, information systems compliance, regulatory compliance and computer systems/software validation. The company can also provide compliant hosting and cloud computing se...
MDI Consultants, Inc.
...problems and concerns and using innovative strategies, has earned mdi the reputation of a company that cares about its clients. Our knowledge of FDA regulatory affairs makes mdi Consultants the leader in this area. mdi has customized over 400 quality systems for companies worldwid...
MEDevice Services LLC
MEDevice Services (MDS) provides personalized, cost-effective FDA and Health Canada regulatory- and quality-related assistance and training to companies of all sizes as well as to entrepreneurs. Services include QSR, 510(k) submissions, U.S. agent, Canadian Class I, II, III, and IV...
RJR Consulting, Inc. is a global life sciences regulatory compliance company founded in 2002, serving businesses, organizations and governments around the world. Headquartered just outside of Columbus, Ohio, we have offices in Brussels, Belgium and Buenos Aires, Argentina with mult...
In order to shorten the product development cycle, medical device manufacturers need to identify as early as possible the world-wide regulatory requirements for new or modified products. Until global harmonization is reached, it is important to develop supporting documents which ar...