With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.
Medical Device Regulation – MDR 2017/745 Consulting Service.
With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.
KEY POINTS for a Smooth Transition
Manufactures should perform an evaluation plan of all their current CE-marked devices in relation to the new MDR guidelines. For some devices, this also means taking into account changes in the classification.
We can support in create a proper Gap Analysis and your custom MDR Transition plan.
The MDR Transition Plan will give you the full picture and overview of your current situation and gaps that needs to be filled to stay compliant.
This will help your company define a proper structured plan, set priority, initiate critical activities on time and smoothly manage the transition.
- Analyze and Asses
- Sub-Task
- Plan and Execute
- Review and Finalize
We will start with a gap assessment and evaluation of your current situation considering the type of product and define the required step to achieve compliance to MDR 2017/745. The work package will be spitted in different sub task. A plan will be defined considering priorities and risk and executed
Each sub task will be reviewed until finalization
We will support you along with all activities needed to take your products into compliance, dealing with NB and authorities, prepare documentation and get ready for certifications audits.
Finally making sure your products are succesfully taken to the market.
EU AR, PRRC and Importer Service
If your organization does not have a physical presence in Europe, but you want to sell medical devices in Europe, you should employ an Authorized Representative (also abbreviated as EC REP or AR) to showcase your company’s compliance to European authorities. It is now a requirement that you must retain an EU AR on condition that you market your medical devices in Europe.
Why choose TS Quality as your European Authorized Representative?
TS Quality is trustable Authorized Representative for medical devices representing several medical device companies globally.
Our knowledgeable and competent consultants will assess your Technical File, ease the process of registration of a medical device as needed, and answer to any queries or apprehensions from the Competent Authorities.
You will have protected online right of entry to all your documents and regulatory evidences, together with labeling information, technical files, language requirements, applicable directives, plans, helpful material and more.
Our huge proficiency with European regulations, will facilitate an effective and well-organized registration route. We provide recurrent and comprehensive updates to all our Authorized Representation customers about significant regulatory updates for European Market . Along with our European offices, we have offices in the Asia region and collaborate with various bodies worldwide. We can help you professionally irrespective of the time zone.
