Understanding complex regulatory business, quality assurance, setting strategy, collecting patient data, preparing clinical studies, establishing synopsis and end points and so on – companies in both medical technology and pharmaceutical drug development have many parameters to conform to.
“It is difficult for any individual company to keep track of all regulations, and therefore 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”, says Anna-Karin Alm, SDS Medteq CEO.
Meeting tougher requirements
The new Medical Device Regulations, MDR, present tougher requirements including clinical trials for companies that develop medical technology products. The requirements are now on a similar level as for pharmaceutical drug development.
“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.
SDS consultants are always monitoring the market in order to provide great support for customers when it comes to new regulations. MDR places completely new requirements on medical technology companies, the requirements are particularly high when it comes to proving the effectiveness and safety of medical devices.
Most 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, according to Anna-Karin Alm.
“We often partner up with smaller companies but do not exclude collaboration with larger companies. We have the expertise and resources to work with the largest developers in medical technology as well as pharmaceutical drug development and combination products. Being comprehensive is our main strength. We provide support for medical technology companies 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”.
Understanding regulatory compliance
As from May 26 2021, all medical technology companies must have a person responsible for regulatory compliance. SDS Medteq can shoulder that role, especially in smaller companies that lack the resources to have a person employed solely for regulatory.
“The revised and updated MDR is a healthy and long-awaited development. In the same way, we strive to become clearer in our own strengths when it comes to clinical trials. We help our customers prove efficacy and safety according to product claims. We see a bright future ahead of us”, says Anna-Karin Alm.