Medical Regulatory affairs
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Viewing ALL listings in Regulatory affairs
Your Partner in the Global Life Sciences Nordson MEDICAL makes and markets an innovative line of fluid management components, biomaterial delivery devices, and catheter solutions. The Value Plastics line of fluid management components includes stopcocks, quick connect fitting...
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...
Omnica Corp. Product Development
...and resources. Technical personnel at Omnica includes industrial designers, mechanical engineers, electronic engineers, advanced R&D specialists, regulatory staff, machinists and model makers. Our staff are familiar with FDA documentation and have experience in designing for co...
Orchid Orthopedic Solutions
...allow for rapid iteration and product development. Our design centers house a team of industry and clinically-experienced engineers, designers and regulatory experts with diverse orthopedics backgrounds to make your ideas a reality. Forging (near-net shape) A world leader in t...
Creganna Medical, part of TE Connectivity
...various levels of support along the design and development spectrum from program development and test management through to file preparation and regulatory submission. We have supported 50+ pioneering First-in-Human devices and on average, our team secures 1 regulatory approval ev...
...Enhancement EMI – EMC Compliance Safety Compliance Fast-track FDA Approval We are experts in the development, design, documentation, and regulatory compliance of new medical devices. Our knowledge of and experience with regulatory requirements, and of the processes needed...
HS Design Inc.
INNOVATION & IDEA DEVELOPMENT HS Design, Inc. (HSD) utilizes a systems-based approach with a QMS relevant ISO 13485 design control certification for medical device design and life science instrumentation, including high volume consumer medical devices and disposables. Our expert...
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...
...Instruments is a manufacturer of high quality instruments for materials identification and thickness gauging analysis essential for quality control, regulatory compliance, Non Destructive Testing (NDT) and safety. The company's X-ray Fluorescence (XRF) handheld and laboratory ana...
Regulatory and Quality Solutions LLC (R&Q)
R&Q is a team of regulatory and quality experts that provide your company with the best practices it needs to succeed. Our experts are experienced, knowledgeable, and scalable to whatever challenges your medical device business faces during its entire life cycle. R&Q has been built...
Regulatory Compliance Associates Inc.
Regulatory Compliance Associates Inc. (RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. RCA pro...
Regulatory Specialists Inc.
Contact: Robyn ScopisYear Established: 1989No. of Employees: 30 Regulatory Specialists Inc. provides regulatory affairs services to the medical device, diagnostic, and pharmaceutical industries. The company can handle all procedures needed to file for and obtain approval to market...
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...
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...
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...
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...