Map and adopt regulatory demands and QSR to US market

Purpose and goal

During the summer, autumn and winter 2018 a large project has taken place, together with qualified consultants, to adopt current version of QMS (ISO 13485:2012) to EN ISO 13485:2016. Within this scope adoption to the US equivalence (QSR-21CFR 820) has taken place. During the summer and autumn 2018 the technical files for RLS 3 products have been upgraded to match the ISO standards as a base.The production has been transferred to a new partner, Biora, already compliant with US standards and also approved by FDA. RLS is now better prepared for the demands from the american market.

Expected results and effects

The target was to map regulatory requirements for the US market-the sole largest market for RLS products-as well as to map technical demands and the current QMS to QSR to make future product registrations possible. This goal has been achieved: QSR according to 21 CFR 820 is reached as far as possible. Now the work to find a partner for the US market remains as well as registration processes a 510 (k) denovo respectively a PMA. Also some registration of UDI etc needs to be done. Also there is a need for more clinical data for the US market and thereafter the design change process for each product.

Planned approach and implementation

The project has had four parts: Part 1-examine alternative registrations for the US market and overall GAP analysis. This is done. Part 2- Map clinical evaluation and need to match regulatory requirements. Clinical evaluations are done for existing 3 products. Part 3-Review of technical documentation to US requirements. Carisolv and existing PMA has been mapped. The mapping of a 510 (k) for ChloraSolv has commenced. Part 4- Adopt the QMS to US required 21 CFR 820. This is done as far as it is possible. Some minor things remain.