Book a free, no-obligation call to discuss your project
Let’s discuss your business needs and the areas where we could support you and your team.
Our process always starts with a deep-dive conversation to ensure that we understand the challenges that lie ahead of your company, your project ideas as well as risks and opportunities that go with it.
I provide consultations in the following subjects:
European Medical Device Regulation (MDR)
ISO 13485 Medical Device Quality Systems
IEC 62304 Medical Device Software life cycle processes
ISO 14971 Medical Device Risk Management
Verification and validation of Medical Devices
Establishing Regulatory Strategy, Medical Device classification and preparing Software classification documents
Reviewing your submission/certification documentation including the Technical File
Creating Submission Readiness Report with highlighted GAPs
Preparing submission or certification documentation, CE Marking, 510K
Please leave your contact details in the attached form and I’ll get back to you as soon as possible.
