In 2018, Advanced Medical Solutions opted to take part in the MDSAP (Medical Device Single Audit Programme). In January we were pleased to receive confirmation that we have been recommended for certification.

The audit, which covers medical device manufacturers, takes into account the requirements of multiple jurisdictions including Canada, Brazil, Japan, Australia and the United States.

As well as being something the business wanted to be part of it had also become business critical to continue to supply product to Canada. The two-stage audit looked at the complete Quality Management System. The process began well in advance of the inspection, with the entire site team taking part in preparations and also in the audit itself.

The process was a tough one, taking place over several stages. During the audit, some challenges were identified. However, the team worked hard to ensure that every observation and improvement was delivered.

In January, the team were delighted to be told that the auditors had recommended us for certification to MDSAP. The result is a testament to the hard work and perseverance of the Advanced Medical Solutions team.

Sarah Tomkins, Quality Assurance Manager, Advanced Medical Solutions commented:

“The achievement of MDSAP is a great success for both sites, and demonstrates what we can achieve when we work together as a team. Not only does this mean we can continue to sell product in Canada, it is expected to reduce the number of routine regulatory audits from each of the jurisdictions. Having one MDSAP audit each year will negate the need to have separate audits by each country.

This is a huge advantage for AMS in other ways as many of our customers are asking if we have MDSAP status and are expecting that we do, we can now proudly say that we do indeed.“