This consultation is suitable for medical device companies at any stage of development: from start-ups to manufacturers with products approaching conformity assessment.
Navigating the regulatory landscape is a crucial part of bringing a medical device to market. With 20 years of experience, B’IMPRESS has guided dozens of customers through this process: from regulatory planning to submission-ready documentation for MDR/FDA approvals and post-market support.
During this session, we will discuss your product and answer your questions about medical device regulations (e.g., MDR, IVDR, FDA). Our Market Access a/o Quality and Regulatory Affairs (QA/RA) specialists have vast experience and can offer insights on:
- How to enter your target markets
- Quality management systems (ISO 13485, FDA QSR)
- Clinical evaluations (MDR) Performance evaluations (IVDR)
- Biocompatibility evaluations
- Usability engineering
- Medical device software: technical documentation
- Medical device software: cybersecurity considerations
- Medical device software: considerations for ML/AI algorithms
- Medical device software: Software Testing for MDR, incl. agentic AI
- Medical device software / DTx / DiGA / App: market access and repurchase, connect with insurances
You will get personalized answers to questions that are specific to your medical device project and relevant for advancing with your project.
Following the initial consultation, further support from our specialists can be agreed depending on your needs.
Tailored QARA support packages (fixed price / hourly priced), consider for example our Regulatory road map service package.
Deal requirements: initial product idea
Deal requirements: initial product idea
We will reach out to you and set up a brief call to discuss and learn more about your company and project and agree next steps.
Get a first contact here – for free.
You could an appointment here, too, via calend.ly.
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