REGULATORY COMPLIANCE AND MEDICAL DEVICE DEVELOPMENT IN ONE COMPANY
We are your single source for helping you develop user-oriented medical devices that comply with national medical device and IVD device regulations.
Ensuring that your company complies with all of the regulations and laws pertaining to your business can be challenging. Still, working with global or local authorities and regulatory agencies on specific issues affecting your business is an important part of bringing new products to market and continuously apply to revised laws and regulations. Based on insight and deep understanding of the medical device business our consultants can ensure a well-structured and time reducing regulatory process from first idea to post market surveillance.
Assuring the right quality in all aspects of your business is vital for your company’s success. We understand your business and are able to help you in developing a Quality strategy - uncover, describe, implement, communicate and follow-up on the processes and guidelines needed to efficiently apply to specified standards.
R&D is an investment in your company’s future. Constantly having new products in pipeline is the key to developing your business and be in front of your competitors. Reducing time to market can be hard working in an area with focus on constant innovation and development of ground breaking technology.
In cooperation with LiNA Medical, Medicologic has developed an advanced single-use surgical instrument for laparoscopic gynaecological procedures. The instrument, which used to be a product for repeated use, improves patient safety and increases both the surgeon’s efficiency and the capacity of the department.