Mån 29 nov / År 39 / Nr 4 2021

Better regulatory understanding with Mediteq

For a small medical device company, it may be a challenge to keep track of everything that has to do with regulatory procedures and documents, but with Mediteq as a supporting partner anything is possible.

Regulatory procedures can be complex and new legislation can change the requirements significantly. The pace is usually high when it comes to design and development projects of medical devices and a lot of time and money may be wasted if projects are taking the wrong turn. But how can small and medium-sized companies with limited resources determine which path is right? Mediteq has the answer.

Getting things done the right way
Too many medical device projects end up with a giant hole in the budget due to expensive and time-consuming development, verification, and clinical validation processes. Mediteq offers guidance and support in a personal, professional, and customer-oriented way, by always ensuring that the path taken is the very best for the customer in the long run.
“What we do is essentially to guide our customers through regulatory requirements for medical devices. We help them identify the gaps in the current documentation and compile the necessary information. We guide customers through regulatory requirements, market access worldwide and CE marking of medical devices. We can provide answers to questions about product documentation, quality management as well as provide services like PRRC and customer adapted training”, explains Helen Sandelin, CEO and Senior Consultant at Mediteq.
Helen states the advantages of working with Mediteq: “With our help medical device projects, companies and clinical scientists can avoid costly mistakes. It is all about doing the correct type of testing and clinical validation, include it in the technical documentation and thereby showing that your product complies with safety requirements for the selected markets”.

Based on solid experience
Mediteq gives customers control over their regulatory process from the start. Helen Sandelin explains why this is so important:
“All manufacturers of medical devices are responsible for ensuring that the product is safe to use and must also demonstrate that it fulfils its purpose. This must be verified and well documented. The main challenge is to compile, and document correct and sufficient data from testing and validation activities. This is our core expertise”.
Helen Sandelin’s experience in medical devices and systems goes all the way back to 1995. She established Mediteq in 2007 and has built up a strong team of experts in the field. The company is operating from Jonsered, just outside of Gothenburg.
Aside from being a partner to companies in medical technology, Mediteq shares knowledge in the competence network Mediteq Forum. Having access to the right knowledge at the right time can make a whole world of difference, especially when it comes to introducing medical devices on different markets.

Meeting new requirements with PRRC
Quality assurance, regulatory affairs, medical device design control and related IT-services are some examples of key competences at Mediteq. For companies with less than 50 employees Mediteq also offers a comprehensive PRRC-service. Having an appointed PRRC, person responsible for compliance with the regulations, is a new requirement for MDR and IVDR.
“Manufacturers and authorised representatives must have at least one designated person with regulatory competence who is responsible for compliance with the regulations. The tasks include ensuring that required technical documentation is drawn up and kept up to date, and that PMS, vigilance and reporting obligations are complied with. In addition, the conformity of the products must be checked before they are placed on the market”, explains Petra Rosén, Senior Consultant at Mediteq.
Micro- and small-scale manufacturers will be able to subcontract their PRRC functions to third parties that meet the qualifications specified. At Mediteq, the required expertise is available to act on behalf of the customer.