Medical Technology development is complex and requires experts within several unique disciplines. SDS can complement the resources you have internally or take responsibility for a full project. The idea is simple but the solution intricate. We call it the SDS difference.
To guide you through regulatory, quality, and strategic challenges of your Medical Device, IVD, or Combination Product.
The SDS difference
Our consultants can provide you with unique expertise to assist you with complex projects that require intricate solutions.
Regulatory Affairs Experts
Having the right understanding of the regulatory requirements of your product, means everything for your success. We will help you to assure to identify your relevant considerations.
Already from the beginning, you need to carefully document your product information to secure it is useful for your submission. We will support you through this process, and in communication with authorities, from start to end.
Quality Assurance Experts - Technical documention
During product development of a Medical Device, IVD or Combination Product, the thinking "if it was not documented, it did not happen" is a valuable mission. We will guide you through securing product documentation compliance.
Quality Assurance Experts - QMS
According to regulations, a medical device must be developed following the company QMS. We will help you through a step-by-step approach, to secure you are investing time in the procedures relevant for your current development phase.
In order to assure the QMS and product Technical Documentation are in compliance with applicable regulations, it is valuable to execute gap analyses at certain points.
Project Management-Medical Device/IVD/Combination Product development
Project Management plays a central role for the product development of a Medical Device. We have got extensive experience in leading the quality and regulatory work, and can support you in building and managing the team needed.
Person Responsible for Regulatory Compliance (PRRC)
As required by MDR, every manufacturer putting a Medical Device on the EU market have to have a person who is responsible for the regulatory compliance of the product connected to their company. With SDS medical device experts, we can act as the PRRC for your company.
Courses and Seminars
If your company is new in the Medical Device world, it will be valuable for your team as well as for your upper management to get a clear picture of the regulatory road you have in front of you. We are used in holding trainings adapted to each specific type of product.
Developing Business Strategies
At SDS MedteQ, this is where we really see what difference we can make for your business! We dare to say that these initial hours of discussions are where you will have the biggest impact on the success of your product and your business.