MDR/ IVDR Quality Management System Support
Customized Implementation Support for Your QMS
Your profile
medical device, in vitro diagnostic device, or medical device software company in the process of establishing a compliant QMS and a sound regulatory strategy
trying to avoid QMS implementation pitfalls
aiming to streamline and customize SOPs and processes
in need of guidance and detailed support on specific topics and documents
requiring expert advice on establishing a regulatory strategy and a QMS that works for your company, rather than against it
Our profile
regulatory experts with 65+ years of experience in medical devices, medical device software, in vitro diagnostic devices, and cybersecurity
support for small to global healthcare companies in bringing their products to market
excellent understanding of the needs and requirements for a compliant QMS (ISO 13485, MDR, IVDR, 21CFR part 820)
committed to providing customer-specific lean solutions to fulfill regulatory requirements
individual pragmatic solutions to your inquiries based on well-established QMS frameworks, as opposed to an out-of-the-box one-size-fits-all approach
It's a match!
In order to find out whether we can support you efficiently with your QMS documentation and implementation and your regulatory questions, please use the link below to book a FREE 30-MIN CONSULTATION with one of our experts.