In medical technology, the highest quality standards and compliance with regulatory requirements are essential for patient safety and therefore long-term market success. Our comprehensive Regulatory Affairs and Quality Services help you to develop your products efficiently and in compliance with regulations and to obtain approval in the respective target markets
From the Development to the Approval of your Medical Device, We are Your Partner – for More Safety, Efficiency and Innovation.
Our Services at a Glance
- Quality management: We implement and optimise quality management systems in accordance with ISO 13485 and ISO 9001 to ensure product quality and process reliability. We are also familiar with the requirements of the FDA – and we monitor the activities of the US authority with regard to 13485 very closely.
- Risk management: We use systematic risk analyses to identify and evaluate potential hazards in order to maximise the safety of your medical devices.
- Technical documentation: We create complete and standardised technical documentation that meets the requirements of the regulatory authorities and accelerates the approval process.
- Usability engineering: We focus on developing user-friendly products that fulfil both user requirements and legal requirements.
- Clinical evaluations: We conduct in-depth clinical evaluations to demonstrate the performance and safety of your medical devices.
- Process modelling: We analyse and optimise your business processes to increase efficiency and compliance in the product development and manufacture of medical devices.
Detailed Information on our Services in Reg. Affairs & Quality Services
With over ten years of experience in medical technology, we offer interdisciplinary expertise ranging from mechanical and mechatronic systems to software solutions. Our commitment to quality and safety is reflected in our work and supports you in successfully bringing innovative and safe medical devices to market.
Benefit from our full-service portfolio in medical technology – we look forward to your challenge!
Talk to our Experts for Regulatory Affairs & Quality Services
Stephan Drozniak
Managing Director
invenio Healthcare Solutions GmbH
invenio Healthcare Solutions GmbH
Sossenheimer Weg 32
65824 Schwalbach am Taunus
Contact me
P +49 (40) 1806571-51
M +49 (178) 4571675
Leo Zeimetz
Head of Business Unit
Product and System Development
invenio GmbH Engineering Services
Eisenstraße 9
65428 Rüsselsheim am Main
Contact me
P +49 (6142) 899-247
M +49 (172) 6638452
Would You like to contact us?
Gladly we are at your disposal for any questions!
