510k fda regulatory affairs consultants. We shape new cardio vascular imaging medical devices through fda cdrh 510k pma approval. Our process yields iso ansi gmp aami compliance.
JD Consulting is a medical device consulting firm for regulatory compliance, medical device manufacturing and engineering excellence and process validation.
FDA Consulting, LLC offers FDA regulatory compliance consulting for medical device and in vitro diagnostics. Domestic. International. ISO 13485. FDA 510k.
Foy Medical Consulting offers help with 510k, PMA, De Novo, IDE or any of your FDA Regulatory Consulting needs. Available for Medical Devices, Biologics, Drugs or Combination Products
The RC Insight Group provides consulting services in the fields of regulatory affairs (including preparation of IDE/IND, PMA and 510K submissions), competitive intelligence gathering, clinical trials management, quality systems regulations and strategic p
FDA Consulting, LLC offers FDA regulatory compliance consulting for medical device and in vitro diagnostics. Domestic. International. ISO 13485. FDA 510k.
LEC Assoicates INC provides regulatory and toxicology support in the USA and internationally focusing on Euorope and Canada. Providing drug, OTC, cosmetic and medical device FDA 510k, substantial equivalence, labeling, dossiers, compliance testing and su
BioPharm Devices is a real-time online database featuring medical device and corporate profiles, management and R&D contact directories and forward-looking intelligence using searchable 510k regulatory filings, clinical trials and IDEs
Jens Medical consulting provide Medical Device Regulatory consulting such as medical device registration, GMP/ISO 13485 consulting for medical device or IVD manufacturer including US FDA medical device 510k PMA consultant, Health Canada medical device reg
Consulting Project Management Medical Device Health Care Regulatory Quality Management Systems Complaint Handling CAPA Warning Letter Process Validation Vigilance Design Validation 510k CE mark
Serving the quality assurance, regulatory affairs and medical device regulatory compliance needs of the medical device industry-ISO, GMP, 510k, IDE and PMAA
MDI Consultants: FDA medical devices consulting company for the medical device, pharmaceutical and food industries on FDA quality assurance, regulatory compliance and clinical issues for US and EU compliance.
This site reports on the findings of the research study "A Comprehensive Analysis of the FDA 510(k) process - Industry Practice and Implications for Reform." Investigators: John Linehan, Jan Pietzsch
Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, cosmetics, biologics and blood.
bioSell is a full service corporate partner. We have expertise in business development, regulatory, and product distribution. Our team has a proven track record of managing and growing medical product lines and steering medical products through FDA regu