April 6, 2017
As digitisation is moving fast forward, the requirements on medical devices are rapidly increasing. Søren Rangstrup is the Development Manager for Elos Medtech’s own products at Elos Medtech Pinol in Denmark. He has been involved in the project of turning all of Elos Medtech’s IFU documents into digital files. We met up with Soren for a nice chat to discuss the project, the advantages of digitisation, and how the regulatory landscape is changing.
As the Development Manager at Elos Medtech Pinol, I am responsible for developing Elos Medtech’s own products, primarily for the dental industry. My main responsibility is to make sure that our own development projects are executed within the agreed timespan, budget, quality and regulatory requirements. I am very passionate about developing medtech products that make a difference for the users and increase the quality of life for patients. I really like the combination of working with complex products and at the same time leading dedicated cross-functional teams in a highly regulated industry.
Yes, IFU is short for Instruction For Use and describes the intended use of a product and how to use it. The purpose of the project was to replace the existing hardware of the IFU documents with digital files and make them available on Elos Medtech’s website. There were two main activities in the project: number one was to create an intuitive website for identifying and downloading the digital IFU documents, and number two was to verify and document that the website meets the regulatory requirements.
There are several advantages of turning IFU documents into digital files. You have the opportunity to create digital demonstration to instruct the user on how to use the product correctly. Digital communication brings the opportunity to create video files that demonstrate the correct use of the medical devices, and we can easily upload them to Elos Medtech’s website and other web portals such as YouTube. You can quickly update the digital IFU documents based on post-marketing surveillance data and thereby further increase safety. There are also some cost-reduction and environmental benefits of using digital IFU documents as you do not have to print one IFU for each product.
The regulatory requirements have increased over the years. The Medical Device Directive (MDD) will be replaced by the Medical Device Regulation (MDR) during 2017, which will affect all medical device manufacturers. The new regulation involves increased requirements on clinical evidence affecting both cost and lead time for new development projects.
Today, you must follow the MDD in order to CE-mark your product, which is required for selling medical devices in Europe. The MDD is related to safety and efficacy of medical devices and describes the requirements on how to establish quality management systems for medical device manufacturers as well as the requirements for product development processes. Elos Medtech’s dental products must now comply with the new MDR regulation, and we have prepared for this.
Yes, we are expanding the product line for our existing digital dentistry solution Elos Accurate® and working on a new concept on a torque wrench for fastening the abutment screws. We are also preparing a market registration in the US for a new product, which is exciting.
Marketing Communication Manager
Elos Medtech AB
Tel. +46 730 86 26 14
Find the answers to your questions, watch our how-to videos, download relevant documents, and receive direct support from our dental expert.