While the services we offer can be described in general terms, we know that every project is unique. To achieve a seamless approval process, we recognize that experience in several areas are of highest relevance. This is where our consultants contribute and make an important difference.
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.
From the beginning, it is important to strategically 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
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
Quality Management System (QMS)
According to regulations, a medical device must be developed following the company's 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.
A gap-analysis is a great way to understand the maturity of the company QMS or product technical documentation at a certain point in time. We are experienced in walking through the documentation, to identify gaps and improvement possibilities
Project Management-Medical Device/IVD/Combination Product development
Project Management plays a central role for the product devel-opment of a Medical Device, IVD or Combination Product. We have 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 placing a Medical Device on the EU market must have a person who is responsible for the regulatory compliance of their product(s). Our advisors may 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. Knowledge of the regulations will enable you to make well-informed decisions, and may help shorten your way to the market. We routinely hold training sessions tailor-made for spe-cific types of products.
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 those that will make the biggest impact on the success of your product and your business.