Tor 7 dec / År 41 / Nr 5 2023

Regulatory and quality services with a smile

Regulatory compliance and quality management in the medical devices industry are often perceived to be complicated, complex and cumbersome. The team at Mediteq challenges this perception, and is helping a growing number of customers see that this important work can be simple, value-adding and even fun.

“We bring energy and flexibility to solve specific customer problems, rather than standardized templates,” explains Helen Sandelin, who started Mediteq in 2007.

She adds, “We aim to keep things simple. We zoom in to help our customers identify exactly what their regulatory or quality needs are. Then we provide them with the most efficient and pragmatic solution to help them improve — without compromising any compliance requirements.”

It’s an approach that’s been working. Since 2014, when Helen took the decision to expand the company, Mediteq has had an exceptional growth—going from one to five consultants and broadening its offering to include medical devices consulting, training and networking services.

Customers, including Mölnlycke Health Care, Vitrolife and startups like Domitor, tap into Mediteq’s expertise and energy to keep abreast of continuously changing global regulatory and quality management requirements.

The action-oriented company also offers customized training, as well as strategic and operational consulting support, in areas such as CE marking, FDA approval processes, management system certification, product approvals in other markets, internal audits, etc.

What’s more, the company has set up Mediteq Forum, a networking and knowledge sharing arena for medical devices professionals. The company arranges six activities per year for forum members.

Helen and the team base their work on the latest standards and directives. They pride themselves on making it as easy as possible for their customers to keep up with, implement and comply with relevant regulations; for example, those currently being introduced by the European Union in the wake of recent hip and breast implant scandals.

Besides participating in ISO and IEC standards development, the company is also a preferred supplier to the Swedish Standards Institute (SIS).

Summarising what differentiates Mediteq, Helen Sandelin has a simple answer, “We love standards, but we are definitely not a standard company!”