In a gap analysis, we start with a description of the MDR/IVDR regulatory framework. This will reflect the requirements your product and company need to reach MDR/IVDR compliance accordingly, either from scratch or for MDD/MDR and IVDD/IVDR transition, respectively.Learn more
Regulatory Compliance Strategy
Timely analysis of the impending, sophisticated regulatory requirements is key to develop a basic strategy to further develop the company`s medical device and in vitro diagnostic business in the European market and to ensure gapless regulatory compliance.Learn more
Technical Documentation Compilation & Update
The Technical Documentation (TD) is a basic requirement no matter which risk class your medical device belongs to. It demonstrates compliance with the applicable and relevant legislation, such as the medical device regulation EU/2017/745 (MDR) and the in-vitro diagnostic regulation EU 2017/746 (IVDR).Learn more
Quality Management System (QMS) Setup
Adequate quality management is crucial for the manufacture of medical devices in accordance with the statutory regulations. Furthermore, customers demand proof of the quality of a medical product – a QMS creates confidence.
Post-Market Surveillance (PMS)
With the introduction of the MDR/IVDR, the requirements for market observation are increased by obligations in reporting and interlocking vigilance and PMS.
Unique Device Identification (UDI) System
With MDR / IVDR implementation, the Unique Device Identification (UDI) System became mandatory for MD and IVD manufacturers for identification and registration of medical devices.
Notified Body Selection & Coordination
MDR / IVDR implications not only affect manufacturers but also Notified Bodies. Early contact with MDR / IVDR designated Notified Bodies is key to compete now and in the future in the Medical Device market.
Person Responsible for Regulatory Compliance (PRRC)
The person responsible for regulatory compliance (PRRC) is a new position defined in Article 15 of the MDR/IVDR Regulations. Legal Manufacturers and Authorized Representatives must each have their own PRRC. Legal obligations are associated with this role and a certain skill set must be fulfilled.Learn more