Medical Device Qualified Supplier Directory
Regulatory affairs and compliance Suppliers Directory
Regulatory affairs consultants ensure that companies comply with regulations that affect the IVD industry. They can offer advice thoroughout the design, development, and manufacturing processes. In this directory, you'll find knowledgeable regulatory affairs specialists that can help IVD manufacturers stay in compliance.
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Collagen Solutions develops, manufactures and supplies medical-grade collagen biomaterials for use in research, medical devices, and regenerative medicine. The company provides product development and contract manufacturing services, including technology transfer and regulatory sup...
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...
Surgical Technologies, Inc.
Surgical Technologies Inc. offers full-service medical device contract manufacturing. STI applies lean sigma principles to assure high-quality/cost-efficient assembly, packaging and sterilization services in a variety of different ISO Class 7 & 8/Class 10,000 & 100,000 controlled e...
Donawa Lifescience Consulting Srl
DLC, headquartered in Rome, Italy, and founded by a former US FDA CDRH official who serves as President of the company, is a regulatory and quality system services consulting firm and full service contract research organization (CRO) for medical devices, including in-vitro diagnost...
Freyr is a Global Regulatory Partner offering a full suite of regulatory services for global regulatory compliance requirements for large, medium and small Medical Device and In Vitro Diagnostic Device (IVD) companies. Freyr’s global team of qualified professionals have expertise i...
JKS & Associates
Contact: John Suzuki Year Established: 1993 No. of Employees: 2 Key Clients: Pfizer, Integ, Ohmeda, Liebert (Emerson Electric), Xerox, IBM Global Services, AMO, Cordis, Alcon. JKS & Associates provides cost-effective software consulting for small and large manufacturers in requi...
MakroCare, an international management consulting services firm, supporting global clients through its 5 divisions - Consulting, Commz, CRO, SMO, and Informatics. Offering services in regulatory affairs, risk management, regulatory compliance, clinical trial management, biometrics,...
NEO Tech (NEO Technology Solutions)
NEOTech combines the strengths of three leading contract manufacturers: NATEL, EPIC, and OnCore. NEOTech serves the medical, defense/aerospace and industrial markets. NEOTech offers product engineering services, manufacturing and testing of microelectronics, cable & harness, PCBA...
Tecno-med Ingenieros is a consultancy company located in Barcelona, Spain. Our goal is to provide regulatory support and expert advice for manufacturers, importers, distributors and exporters of medical devices as well as all associated service providers. We are specialists in the...
Thomas Regulatory Resolutions
TRR is a versatile RA/QA consulting firm in the Quality Auditing, Quality Management Systems, Regulatory Affairs, Global Regulatory Submissions (including FDA and European CE Mark, and other geographies) and Compliance (Audit Preparation, Audit Training, Audit Defense, Audit Suppor...