August 20, 2010
- Despite the recent changes to the Medical Device Directive there are still lots of differences between medical device development and drug development, says Helena Fenger-Krog. “Our customers want to talk to people who understand their challenges and I am excited about being a part of the increased focus on services for medical devices here at A+ Science.”
The appointment of Helena as MedTech Director is yet a step in an increased medical device focus at A+ Science. Helena has 25 years of experience in the medical device industry with leading positions in several companies. Most recently at SciBase where she was in charge of regulatory affairs, clinical trials and the procurement of CRO services for medical devices.
- Helena will significantly enhance A+ Science service offer to MedTech customers. She has repeatedly brought new medical devices to market approval and can help our customers succeed in a similar manner, says CEO Agneta Franksson. “There are many regulatory challenges facing medical device developers. Helping our customers understand these challenges will not only save time but also free up resources for business and product development.”
The services provided by A+ Science include clinical trials for CE-mark, post-market surveillance and reimbursement-goals. In addition consultancy services for CE-mark and quality assurance are also offered.
Return to news list