Impressing auditors and maintaining ISO 13485 compliance

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Tamer Mölnlycke Care is a joint venture between the Swedish Mölnlycke Healthcare and the Tamer Group, based in the latter's native Saudi Arabia. The venture, launched in 2021, represents an ambitious mission to bring a host of new medical devices and healthcare products to the GCC and MENA regions.

Tamer Mölnlycke acts as a contract medical device manufacturer, making a range of devices for clients from wound care and operating room products to surgical gloves.

 

After launch in 2021, it was clear that Tamer Mölnlycke required both ISO 13485 accreditation and certification from the Saudi Food & Drug Authority in order to commence its work.

But as a brand-new operation, the company had no established quality system or processes in place.

QEHS and Regulatory Manager Omran Falemban knew from previous experience that suboptimal document and quality processes could make his day-to-day work much more difficult - and he was keen to start the new company off on the best possible footing.

It was recognized by company leadership that an integrated electronic quality system offered the best, fastest route to regulatory compliance and optimal operational quality, and the company began the search in early 2022.

Qualio soon emerged as the clear winner.

After becoming a Qualio customer, Omran and the team enjoyed a fast, guided expert implementation built around the company's ISO 13485 accreditation plans.

Tamer Mölnlycke received pre-built content and templates to accelerate their ISO 13485 compliance, and were up and running with their new medical device eQMS in just a month.

Qualio offered a new, powerful way for Omran to manage his quality work, with tasks like document approvals cut from a full working week to less than a day.

But the real measure of Tamer Mölnlycke's Qualio investment came with their ISO 13485 accreditation process - and the company sailed through their audit with flying colors.

And it wasn't just ISO 13485 audits where Qualio provided impact.

Audits from the SFDA and from Tamer Mölnlycke's contract sponsor all ran through the company's Qualio system, attracting positive feedback for the flexibility and speed their eQMS provided.

All of Tamer Mölnlycke's 100 staff, from quality and manufacturing to sales, now engage with Qualio for documents and training. The company plans to wrap all documentation into Qualio in the near future, and Qualio's events functionality will be applied to address any post-market activity, like potential complaints, as their medical devices are distributed to customers.