medical product regulatory Services

International Regulatory Support

International registration dossiers – Provide guidance and support for the development, preparation, and submission of International regulatory marketing authorization submissions. U.S. FDA Agent - Act as a U.S. Regulatory Designated Agent for international organizations and serve as a direct ...

By Intertox, Inc. based in Seattle, WASHINGTON (USA). from Medical Products Regulatory Services Service line

Product Development Services

Strategic Planning – Develop approval strategies including Chemistry Manufacturing and Controls (CMC) and non-clinical and clinical programs. FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical ...

By Intertox, Inc. based in Seattle, WASHINGTON (USA). from Medical Products Regulatory Services Service line

Premium

BSI VerifEye - Compliance Navigator

BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...

By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Services Service line

Compliance Service

We provide in-depth knowledge of the regulatory environment of the medical marketplace. Products are produced in compliance with GMP and the FDA QSRs. Product certifications including, metrology reporting, 51 OK compliance and any customer specified certifications and requirements will be provided as ...

By Inventex Medical LLC based in Niles, ILLINOIS (USA).

Services

A systems partner with experience and expertise. For more than 75 years, FRANK plastic AG has been maintaining successful partnerships with leading companies from the field of medical technology in particular. Besides production issues on complex plastic products, these relationships are also centred ...

By FRANK plastic AG based in Waldachtal, GERMANY.

Quality Manufacturing Services

As an FDA-registered and ISO 13485:2016 certified medical device manufacturer, we manufacture products that meet all specifications and relevant regulatory requirements. Thanks to rigorous quality management throughout our manufacturing process, we build medical products that work as intended time and time ...

By Domico Med-Device based in Fenton, MICHIGAN (USA).

Strategic Preclinical Consulting Services

We will partner with you to define, develop, document, and deliver a preclinical strategy, encompassing all aspects of product validation and verification, to bring your product to ...

By Avania based in Brunswick, AUSTRALIA. from Services - Consulting Service line

Consulting Service

We advise you fully in all matters relating to your medical device - regulatory, technical and economical - during all stages of the product life cycle. ...

By BYTEC Medizintechnik GmbH based in Eschweiler, GERMANY.

Testing, Programming & Validation Services

Sanbor Medical offers a full range of medical device testing and programming capabilities to help our customers delight their users and succeed long-term. ...

By Sanbor Medical based in Allentown, PENNSYLVANIA (USA). from Manufacturing Services Service line

Business Process Services

For many healthcare innovators, opportunities to grow can outpace their ability to scale. Building capabilities in-house requires time and resources that many firms don’t have in the evolving commercial and regulatory demands of the healthcare ...

By Emergo by UL based in Austin, TEXAS (USA).

Medical Device Regulation Compliance Services

Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. Risk Assessment & ...

By Chemical Inspection & Regulation Service Limited (CIRS) based in Hangzhou, CHINA.