ARCHIVE

FDA Recognizes AMS2750

6th December 2017

The Agency’s Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred. A pyrometry standard originally developed for the […]

MedAccred Makes Its Mark

4th December 2017

The industry was buzzing when Stryker announced in July that it would require its future suppliers of critical manufacturing processes to be accredited by MedAccred, a medical supply chain oversight program formed in 2010 by the Performance Review Institute. The program is gaining traction as more medtech OEMs are beginning to require accreditation, but Stryker’s […]

US Government Issues $1 Million Multi-Year Award to Assist MedAccred

3rd October 2017

GENEDGE received a $1 million multi-year award from the National Institute of Standards and Technology (NIST) for assistance in the Growth through MedAccred project. The award was issued by NIST in response to the Manufacturing Extension Partnership (MEP) Competitive Awards Program submission by GENEDGE. The request for proposal related to critical manufacturing technologies; supply chain […]

Medtech Insight highlights MedAccred

22nd August 2017

SUPPLIERS OF EIGHT SPECIAL MANUFACTURING PROCESSES – including sterilization, welding and heat treating – will have to be accredited to industry-managed supply-chain oversight program MedAccred if they want to do future business with device giant Stryker. “Awarding business based on accreditation [to MedAccred] is the end goal,” the company’s manager of supplier controls told Medtech […]

Flex Leads the Way for PCBA Manufacturers with the First Accreditation from MedAccred

21st November 2016

Flex has become the first company in the world to receive accreditation for the manufacture of Printed Circuit Board Assemblies (PCBAs) from MedAccred. The company’s site in Aguascalientes also became the first company in Mexico to receive an accreditation from MedAccred of any kind. In order to achieve the certificate from MedAccred, the team at […]

SINBON Electronics is the First Company in Asia to Achieve Accreditation from MedAccred

11th November 2016

SINBON Electronics has become the first in Asia to gain an accreditation from MedAccred after meeting all the requirements for Cable and Wire Harness Assemblies. During a challenging four-day audit, the SINBON team in Jiangyin were successfully able to demonstrate that their manufacturing processes are fully compliant with MedAccred’s Audit Criteria for Cable and Wire […]

MedAccred’s First Accreditations for Plastics Injection Molding Awarded to MTD Micro Molding and BMP Medical

12th October 2016

In early 2016, MTD Micro Molding and BMP Medical volunteered to facilitate the pilot process for MedAccred’s new AC8160 Audit Criteria for Injection Molding. Both companies participated in the challenging and highly technical critical process pilot audits. As active members of the MedAccred Plastics Task Group, which is comprised of technical experts from a number […]

Medmarc Recognizes Importance of Supplier Controls to Mitigate Products Liability Risks

14th September 2016

Medmarc, a leading medical device industry insurer specializing in product liability risks facing medical technology and life science companies, has outlined how it believes programs like MedAccred’s critical process supply chain accreditation system are helping the medical device industry to establish, according to Medmarc, “better supplier controls” which “could, over the long term, result in fewer recalls, […]

The Vital Link Between Critical Process Quality and Patients

18th August 2016

A new blog authored by MedAccred Management Council member, Robert Berger, Vice President, Contract Manufacturing, Minimally Invasive Therapies Group, Medtronic, has been published by MPO Magazine. In this piece Robert talks about the importance of connecting the operator to the patient and how core elements of the Shingo Model’s Cultural Enablers Principle (respecting the individual, […]

New Brazing Audit Criteria Released by MedAccred

17th August 2016

In response to industry demand, the MedAccred program has recently released new audit criteria for brazing. AC8102/1 MedAccred Audit Criteria for Heat Treating – Brazing will be used during MedAccred audits conducted at companies performing brazing in an atmosphere or vacuum furnace or  in a dip salt bath. The new audit criteria were developed by […]