Safety and efficiency
Approvals
More than 25 years of experience in medical device approvals. All risk classes from I to III in Europe, USA, Canada, Australia, China.
Development of approval strategies, identification of applicable regulations, qualification and classification of your medical devices, structuring and specification of region-specific approval documents.
We are happy to support you with your approval processes.
QM systems
The comprehensible implementation of the requirements for a QM system and its processes ensure fast and smooth approval - and of course the quality - of your medical products.
Do you want to build on an existing QM system, update it or open up additional markets?
Or would you like to implement a new QM system? Use our preconfigured sample processes and templates.
Project planning
Medical technology projects are extremely complex. They are multidisciplinary and have to fulfill an enormous number of regulatory requirements.
The number of associated activities, responsibilities and interfaces is correspondingly high.
With our preconfigured project plans, you can reliably and completely cover all activities for your QM processes, technical documentation or approvals.
Harmonization of QM systems
Merge approvals
International approvals differ in the information required, the structural design and their documents.
You define the regions in which you want to approve your product. We create the appropriate document pool for you from which we compile the various approvals.
Project management for medical devices
The GAP Analysis
Do you already have an existing QM system or approval documents that need to be brought up to date or expanded to include regulations and approval areas?
We carry out GAP analyses for you. We compare the current status with the target status, uncover gaps, identify corrective measures and provide you with suggestions for correction.
Documentation
Documents that reliably and traceably meet the requirements of current standards, directives and regulations. We create a redundancy-free document pool with which you can compile your approval documents across regions.
Training
Due to regulatory requirements, a number of training courses must be carried out to ensure the competence of employees.
In addition to the standard QM process training, we can offer you a range of specific training courses:
- Quality Management System
- Product approvals
- Medical Device Consultant
- Person Responsible for Regulatory Compliance (PRRC)
Dieter Velte
owner
Ferdinand Verte
Project Manager QM and Regulatory Affairs