Sharing Valuable Experience
Raw Material Assurance
To ensure your success, Bard Peripheral Vascular OEM Products provides you with implantable experience, regulatory heritage and proven technology used to produce quality surgical textiles, ePTFE, angioplasty balloons for stent delivery, and guidewires. The decision to purchase from an OEM supplier requires careful consideration. You need a company that will help you through the development phase, and also be there for the long term when you commercialize your product. Our experience enables us to provide you with the best customer support possible.
Bard Peripheral Vascular OEM Products’ manufacturing plants are routinely audited by internal teams as well as by domestic and international government agencies to ensure the highest quality production. All facilities are ISO 13485:2003 certified.
Our business is built on protecting our customer’s intellectual property, and we are committed to protecting your disclosures. We also understand the need for open discussion, and will execute a Non-Disclosure Agreement at your request.
The Bard Peripheral Vascular OEM Products Quality Team uses the latest inspection equipment and processes to certify that your products have been manufactured to GMP standards and meet the requirements of your specifications. All manufacturing facilities operate under 21 CFR Part 820 Quality Systems Regulations.
It is common for raw material suppliers to leave the medical industry with little or no notice. That’s why we maintain plentiful stocks of the critical raw materials used to manufacture our products. This practice insures continuity of supply and if needed, allows long lead times for new qualifications.
The component you purchase from Bard Peripheral Vascular OEM Products frequently shares the same technology our parent company,
C. R. Bard, uses on its own FDA cleared for market, CE-marked products. As appropriate, these branded products – with their years of clinical and regulatory acceptance – can be referenced in your company’s submission.