Medilink WM patron MasterControl discussed the Medical Device Single Audit Program (MDSAP) at their Masters Summit. Luis Jimenez, vice president of business development at Brandwood CKC, discussed the program, and provided expert insight on how it benefits medical device manufacturers.
Advances in the fields of generative medicine, computational biology and medical imaging are paving the way for personalized medicine, which promises to be a key driver of the combination product market. In 2018 alone, there were a record number of personalized medicines approved, accounting for 42% of all 2018 drug approvals, according to the Personalized Medicine Coalition (PMC). More opportunities remain for personalized medicines to make a significant difference in patients’ lives in the coming years.
Since advanced technology has moved medical device innovation into the fast lane, it stands to reason that global regulatory agencies would step up and help keep the momentum going — and they have. Over the past few years, the International Medical Device Regulators Forum (IMDRF) has been developing a harmonized regulatory approval program called the Medical Device Single Audit Program (MDSAP).
What is MDSAP?
By definition, MDSAP allows a recognized auditing organization to conduct a single regulatory audit of a medical device manufacturer’s quality management system (QMS) that satisfies the requirements of multiple regulatory authorities participating in the program. In simpler terms, “Some of the toughest regulators in the world come together and agree on a standardized audit, and if you are a participant, they will say you’re good to go,” said Jimenez.
MDSAP is a ground-breaking program and will most likely become a game-changer for companies competing in the global medical device arena. To give some perspective, in order to remain compliant, medical device manufacturers expect surprise visits from large regulators. These inspections are unannounced and require the company’s quality team to be dedicated to the audit. Sometimes, organizations have quality team members specifically for supporting audits as these site visits can occur frequently.
Further, going global with a medical device requires preparing submission materials according to each country’s regulatory guidelines, which includes translating specific documentation. Then, you need to present your submissions to each country you want to market your product in. Coordinating all the documents and effort for this process is arduous and stressful. A single error in a submission can result in the delay of a market entry and a significant loss of revenue.
The MDSAP Audit
Ultimately, MDSAP will present tremendous opportunities for medical device manufacturers to accelerate product life cycles. One thing Jimenez pointed out is MDSAP is a big audit — typically lasting five days with two inspectors on site. This will pose challenges to a manufacturer’s QMS.
The program uses ISO 13485:2016 as a framework, but it’s also a hybrid, so approximately 30 percent of the audit includes what you would see during a CE (European conformity) audit. Regulatory agencies say the requirements of ISO 13485:2016 apply to all organizations regardless of size and type. It also applies to suppliers and other third parties that provide products or product components, including QMS-related services.
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