RegSmart new partner at Uppsala Innovation Centre (UIC)


RegSmart Life Science and the business incubator Uppsala Innovation Centre (UIC) has signed a partner agreement starting February 1, 2023. RegSmart will support UIC start-up pharma and medical device companies with regulatory advice. RegSmart will also contribute to UIC’s special offerings to the Life Science community companies. Uppsala Innovation Centre (UIC) offer innovative startups and … Continue reading RegSmart new partner at Uppsala Innovation Centre (UIC)

Unclear proposal from the EU Commission on how to solve the MDR challenges


Even before the EU regulation on medical devices (MDR) came into force, medical technology companies and doctors were concerned that it would endanger the availability of medical devices in the EU. Unfortunately, the fears have come true. Above all, notified bodies have a limited capacity following the stricter requirements since the MDR came into force. … Continue reading Unclear proposal from the EU Commission on how to solve the MDR challenges

RegSmart new partner at Aleap, the health startup incubator hub in Oslo


RegSmart Life Science has signed an agreement with Aleap, the incubator hub for health startups in Oslo, Norway.  The purpose is to support the innovative early-stage community companies with regulatory advice when developing pharma and medical device products. ”We are excited to partner with Aleap and support their member companies to navigate the complex regulatory … Continue reading RegSmart new partner at Aleap, the health startup incubator hub in Oslo

RegSmart year summary 2022


Another year has passed. And what a year! We have settled in just fine in our new offices at Eklundshovsvägen 5, strengthened our senior consultancy team and added new services to our portfolio. Let us summarize the highlights. A strengthened RegSmart team We have welcomed experts in project management, regulatory drug development and medical device … Continue reading RegSmart year summary 2022

Matthias Rother and Rolf Karlsten

RegSmart adds clinical development plans as service


During September 2022, RegSmart starts a collaboration with Matthias Rother and Rolf Karlsten as sub-consultants to RegSmart aiming at offering clinical development plans within pharma and medical device. “The clinical and regulatory plans are closely integrated, and central parts of the overall development plan” explains Marie Gårdmark, CEO at RegSmart. “We have seen that small … Continue reading RegSmart adds clinical development plans as service

IVD manufacturer – use the progressive roll-out of IVDR in a smart way


The countdown has started. On 26th of May the In Vitro Diagnostic Regulation, also known as IVDR, is entering into force. The aim of the regulation is to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic devices (IVDs), which ensures a high level of safety and health whilst supporting innovation. … Continue reading IVD manufacturer – use the progressive roll-out of IVDR in a smart way