Medical Device Directives Division
At MDSS we are confident that to operate effectively within the constraints of ever changing Medical Device Industry and Medical Device Directives Standards, you need an Authorized Representative who not only represents your company, but does so with your best Regulatory Affairs interests in mind.
Our dedication to our clients is the very reason why you need MDSS as your "Authorized Representative" for Medical Devices, In-Vitro Medical Diagnostic Devices and Active Implantable Medical Devices.
The links below will guide you through the papers and regulations concerning Medical Devices. We hope this will give you more insight and understanding of the Medical Device Directives.
- Know the facts
- The legal & safety aspects of selecting an Authorized Representative & why not to appoint a distributor
- Harmonized Standards
- The lists of harmonized standards applicable to Medical Device Directive 93/42/EEC