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Bridge Med Solutions
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Bridge Med Solutions

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Biocompatibility and Toxicology

http://www.bridgemedsolutions.com/bio_compatibility.php

Transcatheter Heart Valve Therapies. Tissue of Animal origin (AO). Different geographies follow biocompatibility regulations that are specific to their country. The device designers and manufacturers shall comply with geography specific biocompatibility regulatory requirements. For example:. ISO 10993 series for Europe, China, Korea, Australia other geographies. G95-1 Memorandum for FDA. We provide the following consulting services:. Testing for Europe / CE mark. Testing for Japan etc. We will qualify an...

2

R&D

http://www.bridgemedsolutions.com/rnd.php

Transcatheter Heart Valve Therapies. Tissue of Animal origin (AO). Developing new / innovative and superbly efficient products is the goal of any R&D department in a medical device. During the R&D phase though innovation and product development is the focus but quality and compliance remains critical. We provide the following consulting services:. New product design and development. Verification and validation testing (V&V). Identify and recommend design verification and validation testing requirements.

3

Regulatory

http://www.bridgemedsolutions.com/regulatory.php

Transcatheter Heart Valve Therapies. Tissue of Animal origin (AO). USA-FDA: medical devices are classified as class I to class III. Investigational device exemptions (IDE). Humanitarian device exemptions (HDE). Canadian Medical device License (CMDL). Japan, China, Korea, India, and Latin America:. Respective approvals shall be obtained to market the devices. We provide the following consulting services:. Develop strategy for regulatory submission - CE mark, FDA, China, Japan, Australia, and Canada. We wi...

4

Tissue of Animal origin (AO)

http://www.bridgemedsolutions.com/tissue.php

Transcatheter Heart Valve Therapies. Tissue of Animal origin (AO). Tissue of Animal origin (AO). Tissue of Animal Origin. In medical device industry animal tissue (includes animal derived materials) is widely used because of its high performance, durability, and lack of suitable synthetic materials. The manufacturer must follow Commission Directive 2003/32/EC (TSE) and ISO 22442 for regulatory compliance when an animal tissue is present in the final medical device or used as manufacturing aid. We develop...

5

Home

http://www.bridgemedsolutions.com/index.php

Transcatheter Heart Valve Therapies. Tissue of Animal origin (AO). In medical device and structural heart vale industry Biocompatibility, Tissue of Animal Origin, Sterilization, Viral inactivation qualification, EDQM certification, Regulatory submissions and Quality and Compliance is of utmost important. We provide testing and consulting support in all of these areas. CONTRACT MANUFACTURING ORGANIZATION (CMO). We have the required industry experience and focused knowledge to deliver the results.

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1 949 264 1526. Tissue of Animal origin (AO). In medical device and biotherapeutics industry Biocompatibility, Tissue of Animal Origin, Sterilization, Viral inactivation qualification, EDQM certification, Regulatory submissions and Quality and Compliance is of utmost important. We provide testing and consulting support in all of these areas. We have the required industry experience and focused knowledge to deliver the results.

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