Medical Device Qualified Supplier Directory
Good manufacturing practices/compliance Suppliers Directory
Compliance consultants ensure that medical device manufacturers are acting in conformance with government regulations. Good manufacturing practices consultants can provide information to ensure medical device manufacturers comply with FDA's current good manufacturing practices regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities.Use this directory to connect with consultants knowledgeable in the areas of good manufacturing practices and compliance, as well as other areas of medical device design and manufacturing.
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...diagnostic projects and commercialized product plans. Spectrum is a single-source provider for innovative medical device engineering & product manufacturing, molding, formulation, packaging design, customized kitting, & direct-to-user fulfillment. FDA Registered Medical Device...
...of the first articles, final engineering, FDA documentation, and vendor sourcing. If appropriate, we will also coordinate a smooth transfer to manufacturing. Medical Product Development Resources At our 25,000 square foot facility we can build prototypes and first articl...
Impact Analytical is a leading contract analytical laboratory that provides full-service testing support to the medical device industry for class I, II, and III devices through all stages of the product life cycle. Our top-notch services will deliver quality results that are on-ti...
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...
Sefar Inc. is an industry leader in weaving precision fabrics for the medical industry. The company's medical component products increase the speed, safety, and reliability of diagnostics, blood filtration, and transfusions. Its precision monofilament SEFAR MEDIFAB® line is fabrica...
Borghese & Associates Inc.
Contact: Robert N. Borghese Year Established: 1999 No. of Employees: 6 Key Clients: Available on request.Borghese & Associates is a quality system and regulatory consulting firm with extensive experience working with FDA's CBER, CDER, and CDRH. Services include regulatory submi...
MDI Consultants, Inc.
Contact: Alan SchwartzYear Established: 1978No. of Employees: 22Key Clients: Client list supplied upon request. FDA Quality SystemsFDA Regulatory ComplianceFDA Clinical Services to the Medical Device, Pharmaceutical and Food industries Click HERE for an immediate response to y...