Regulatory affairs &
quality management
In today's world, the regulatory environment is subject to constant change, new requirements, and implementation deadlines. The rapid and successful market launch of your medical device is therefore a major challenge. It is essential to implement a qualified process that makes the development from the idea to the market launch compliant with the regulations.
As seasoned partners, we expedite your product's market launch leveraging our hands-on approach and deep knowledge in regulatory affairs and quality management. We handle approval and compliance documentation for medical devices, quality management system (QMS) implementation, and provide support throughout the entire product lifecycle, ensuring ISO 13485 compliance and adherence to local laws.
Our auditor and technical document reviewer teams are ready to examine your QMS, offering mock or internal audits. We will ensure the reliable completion of your development project through our test laboratory and certification body network. The up-to-date knowledge, acquired through our work in IEC standards task groups, will be at your disposal.
We provide more than mere consultancy - our involvement in the daily operations of our sister company, IMT Analytics enables us to quickly understand your company's challenges.
Consulting in the field of quality management systems
Definition of the standards and laws to be complied with for the quality management system. More
Establishment of your QMS
Creation of a Quality Management System including execution of the internal audit and possible mock audits in preparation for certification. More
Consulting in the area of product development
Among other things, the definition of the standards and laws to be complied with for the product's intended use and/or indications for use, specification, usability, verification, and validation as well as the approval strategy. More
Support for verification & validation
In particular, pre-compliance- or standards testing in our test lab or accredited partner companies and certification in a lab in our network. More
Technical documentation
Development of technical documentation respectively DHF/DMR/DHR according to the requirements of the target market. More
Submission
Support in submitting the technical documentation to regulatory authorities notified bodies, or certification organizations to be allowed to place the medical device on the respective market. More
Market surveillance and maintenance
Support in monitoring the device on the market as well as maintaining certifications and approvals, processing of findings from authorities, notified bodies, customer audits, etc. More
Your benefits
Regulatory mastery & efficiency
Proven expertise
We have years of deep regulatory knowledge for Class I to IIb medical devices.
Own product experience
We launched our own products in the market and understand market access challenges firsthand.
Quality assurance
Being ISO 13485 certified ensures high-quality service in all areas.
Rapid testing
Our in-house lab facilitates swift pre-compliance tests for speedy project progress.
Vast network
Our connections with test labs and certifying bodies expedite project completion.
Risk management
Our extensive regulatory expertise helps mitigate potential compliance risks, ensuring smoother market entry.
Contact
Looking for a partner to find answers to your regulatory or QMS challenges? Don't delay — contact our experts today!
Thomas Schwendinger
Head of Regulatory Affairs
& Quality Management