We have Experienced and Enthusiastic Professionals that support your organization to get CE Certification as per EU MDR 2017/745 and 2017/746 for your Devices in a very efficient and reasonably shortest Possible Time and in a Cost-effective Manner.
Transition to EU MDR
We have experienced professionals to perform a systematic, independent gap analysis of CE technical documentation, procedures, and processes to help manufacturers understand what steps should be taken to meet requirements of the Medical Device Regulations. Our in-depth MDR gap analysis is done by most senior consultants and includes below given services:
EU MDD to MDR 2017/745 gap analysis
The review/gap analysis will include the assessment of the following:
Legacy Device Report Review
CE Marking Technical File or Design Dossier
Current device class and product families
Risk management file review
Clinical Evaluation Report(s)
Post-market surveillance (process, plan, effectiveness, PMCF, and results)
Periodic Safety Update Report (PSUR)
Economic Operators Agreements Review, including your European Authorized Representative (EC REP) agreement
Supply and distribution chain management procedures
Relations with your current Notified Body
Product life cycle plan
We will deliver a comprehensive report detailing deficiencies, with recommendations on how to fix them and the order in which you should address them.
EU MDR Consulting & Compliance
This will include the following:
Scrutiny of clinical data and Clinical Evaluation Report (CER)
Increased post-market surveillance requirements
Performing more Post-Market Clinical Follow-up (PMCF) studies.
Preparation and Submission of Periodic Safety Update Report (PSUR)
Based on the above, our professionals will be able to support as per below:
Comprehensive Review of Entire Product Portfolio and Current Certificate Expiry Dates
Review and Assess the Client’s entire Product Portfolio including its:
Legacy Products [CE marked devices under the Medical Device Directives (MDD) 93/42/EEC or the Active Implantable Medical Device Directive (AIMD) 90/385/EEC];
Modified Legacy Products; and/or
New Products currently in the Design/Development Phase.
Confirm whether any Legacy Products and/or Modified Legacy Products have been affected by the new MDR Definitions and/or Reclassification of certain types of products into higher risk classes of devices;
Reassess current classification of devices based on MDR Classification Rules;
Prepare Product Rationalization Strategy Reports for Legacy Products, Modified Legacy Products, and New Products (as appropriate and applicable). which may assist the Client in making internal decisions about whether to maintain and/or bring such products in compliance with the MDR;
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DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.