Sister companies SDS MedteQ and SDS Life Science provides expertise in the extensive areas of regulatory affairs and quality assurance to developers of medical technology products, pharmaceutical drugs, and combination products.
“We have unique knowledge within the company and can make a big difference for our customers and their projects. We can deliver indispensable expertise, especially in complex projects where the development concerns advanced combination products, or products that belong in the borderland of medical technology and pharmaceutical drug development. For such products, we are unique as a consultancy with the extent of knowledge within both pharma and medtech”, says Anna-Karin Alm, Managing Director SDS MedteQ.
The SDS team has expanded over the last couple of years and consists of over 80 experts in all areas related to the development of medical devices, IVD’s, pharmaceuticals and combination products.
The new challenge
In the spring of 2021, a major change took place in the regulatory framework for medical devices. The revised MDR clarifies the standard for clinical trials, increasing the demand of clinical data to be provided. This is to prove the safety and performance of the products for patients.
The introduction of the new MDR regulatory has brought new challenges for companies with existing products on the market or with products that were about to be launched before the regulations.
Many medical technology companies, and especially smaller companies, lack the competence to be able to perform clinical trials to the level required by the new MDR. It is difficult for any individual company to keep track of all regulations.
Making a difference
SDS MedteQ and SDS Life Science are involved as strategic partners throughout the entire regulatory process – from initial development to market launch of new medical devices and pharmaceuticals.
“The new regulations within MDR are a challenge for most medical technology developers, but hope lies in partnering up with external teams that possess the necessary expertise when it comes to clinical project management”, says Anna-Karin Alm.
“We often partner up with smaller companies but do not exclude collaboration with larger companies”, she continues.
In conclusion, Anna-Karin Alm sums up the key advantages of working with SDS MedteQ and SDS Life Science:
“We have the expertise and resources to work with the most innovative developers in medical technology as well as pharmaceutical drug development and combination products. Being comprehensive is our main strength. We provide support for our clients to get to the next level. We also see a strong growth potential, both for us and for our customers, thanks to the introduction of MDR. Here, we can really make a difference”.