medaccred Archives - Medical Design Sourcing

MedAccred gives first PCBA accreditation in Mexico

NEWS RELEASE: Jabil Mexico achieves MedAccred accreditation for printed circuit board assembly at Chihuahua facility

[Photo courtesy of Jabil]

Jabil’s site in Chihuahua, Mexico, has earned the prestigious MedAccred Accreditation for Printed Circuit Board Assembly (PCBA) after meeting the stringent audit requirements set by MedAccred subscribing members – including Baxter, BD, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, Roche Diagnostics and Stryker. It is the only site in Mexico to currently hold MedAccred PCBA Accreditation.

The MedAccred audit and accreditation program is unique as the sole industry-managed supply chain oversight program for key critical manufacturing processes in the medical device industry. The accreditation assures that critical manufacturing processes meet industry consensus requirements, leading to the production of high-quality end products, ultimately enhancing patient…

MedAccred joins The Irradiation Panel

NEWS RELEASE: MedAccred Program Joins Influential Irradiation Industry Association

MedAccred Sterilization Staff Engineer and Auditor Kim Patton [Photo courtesy of MedAccred]

The MedAccred program has become a member of The Irradiation Panel, a renowned not-for-profit industry association representing global and diverse interests in radiation processing.

The panel is comprised of suppliers and users of irradiated products and irradiation services, regulatory bodies, and consultants. Membership currently consists of 46 companies and nine individual members, including Steris, Sterigenics, BD, Smith & Nephew, NPL, Nelson, IBA, Mevex, and Astra Zeneca.

Established in 1966 and based in the UK, it has members from across Europe and beyond, and provides a forum for discussing the advancement, development, promotion, regulation and practice of radiation processing using electron beam, gamma, and X-ray techno…

Contract manufacturer selection tips, tricks and red flags

A few years ago, Vivasure Medical faced an emergency that “nearly shut our company down,” co-founder Gerard Brett said.

“We picked a supplier in good faith — it looked like they had what it took to do the job for us,” he said. “We were working away at developing a part of our product, and we got a phone call with 24 hours’ notice to say the sheriff is going to put a lock on the door of that company.”

The supplier was about 4,500 miles from Vivasure’s Galway, Ireland headquarters where Brett serves as chief operating officer.

“We literally put people on a plane, hired what looked like the CIA, we had black Suburbans, and we backed up to the back of that facility at 2 a.m. and took our stuff out: equipment and materials,” Brett said. “At 6 a.m., it was locked.”

Vivasure Medical co-founder and Chief Operating Officer Gerard B…