Contract manufacturing
MedAccred suppliers first before widening the search if necessary. “It’s a first-stop shop,” she says.
The audit process
Audits are conducted by experienced and trained experts in their fields on behalf of subscribing members – all of which are medical device OEMs. Audits can be carried out across a number of specialities – harnesses, heat treating, plastics, circuit boards, sterile packaging, sterilisation and welding – as well as across borders, with accreditations granted to several companies outside of the US, including the UK, France, China, Romania, Austria, Mexico, Costa Rica and Malaysia.
MedAccred seeks to streamline supply chain processes and simplify quality assurance for businesses.
An accreditation programme with audits built in by experts, it gives suppliers and manufacturers a ‘gold standard’ seal to show they meet a high
level of performance in the medical device marketplace.
Run by a non-profit called Performance Review Institute (PRI) in the US, MedAccred launched in 2013 after the idea was floated at a roundtable meeting of medical device industry leaders held the previous year. Originally inspired by a similar scheme in the aerospace sector, it has since grown into an internationally recognised assessment process that many of the largest medical manufacturing companies look to for suppliers with a proven track record of quality.
The programme “provides consistent and standardised critical process accreditation accepted by the medical device industry resulting in fewer redundant on-site audits by multiple OEMs”, according to the PRI’s mission statement, as well as providing “greater visibility of the supply chain to all levels and sub-tiers that provide critical processes, consistent with regulatory requirements”. The PRI also says MedAccred can help achieve greater efficiencies, continuous improvement and better outcomes. For Dannette Crooms, vice- president of supplier quality at Edwards Lifesciences, these lofty ambitions have been met and have made the programme an essential element of the company’s supply and procurement strategy.
“MedAccred provides us really good control and understanding of our supply base,” she says. “When a supplier has been through the MedAccred process, we know they have a higher level of patient safety and control over their processes.” Crooms says Edwards will look to its list of
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The process shows similarities to the Medical Device Single Audit Program (MDSAP) – a scheme set up by the FDA to harmonise auditing between the US, Canada, Japan, Brazil and Australia.
The major difference – apart from MedAccred being a global endeavour – is that MDSAP was created to ensure that suppliers met requirements outlined in several regulations, whereas MedAccred accreditation applies specifically to critical processes. Because this framework is agreed upon by MedAccred’s members, this often means suppliers have to reach a higher bar than simply satisfying regulatory rules.
Once a supplier has the MedAccred badge of approval, it gives a company like Edwards reassurance and confidence in the quality of the product they will receive.
As well as having to seek MedAccred approval for each process and location involved in the production of their goods, approved companies are reaudited annually, or once every 18 months following three successful audit cycles. “I like to use the phrase ‘stable and capable’ for suppliers with MedAccred [accreditation],” says Crooms, who has worked for Edwards for nearly 15 years.
“It is very important to the market and is growing in importance with more and more influence,” she says. MedAccred initially launched with just Johnson & Johnson, Phillips and Stryker, but has grown to ten members, including other industry heavyweights like Medtronic, Roche and Becton Dickinson.
Commercial and cost benefits In the area of sterile manufacturing, MedAccred is particularly influential, says Crooms, and this is critical to Edwards, which specialises in heart valves and haemodynamic monitoring – both of which require thorough sterilisation to decrease patient infection risk. Previously, the company would have
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