Mi3 achieves MDSAP Certification…
…which is great news if we manufacture the
products you sell in Europe, Australia, Brazil, Canada, Japan and the US. This will
potentially increase the speed at which devices can be brought to market or
changed. Or, if you are currently marketing in Europe, the US and Canada for
example, adding Brazil to your intended markets will become easier as you can
potentially provide evidence of good manufacturing practice from the one broad
audit, which Mi3 have successfully completed in July 2018. Well done Mi3 and thank you to everyone that
contributed to this success!
The Medical Device Single Audit Programme
(MDSAP) is the result of more than five years of work by regulatory bodies from
Australia, Brazil, Canada, Japan and the US and is starting to gain acceptance
in the medical device industry. Being certified with MDSAP means that an
authorised auditing organisation will conduct a single audit of a medical
device manufacturer, sharing the results across the participating countries and
this potentially negates the need to host several Regulatory authority specific
audits over the course of their audit cycles.
One of the key areas of focus for my team is
hosting and preparing for audits. Whether it is a scheduled or unannounced
audit from Regulatory authorities or part of the internal audit program it is a
huge burden on the team and the business. My Technical team can now spend more
of its expert resource on ensuring that the product delivered is of the highest
standard with more focus on continuous improvement and cost effectiveness
projects, and looking at new technologies that can feed New Product Development
while being safe in the knowledge that ISO 13485:2016 and the aforementioned countries
requirements have been met in the process.
Looking forwards to discussing how
Mi3 with our MDSAP certification and wide ranging technical expertise in device
design, moulding, extrusion, assembly, packaging and sterilisation can help
your business achieve success.
Kelly Jackson, Senior Technical Manager at Mi3