Expertise deep-dive
You want to bring Medical Products to the US?
Think about this...
Challenges you face when running through the compliance and registration process
Complexity
Extended Documentation
Complience
In depth knowledge
Contact us for a free consultation.
If you are planning to enter the FDA and MDR-CE registration process or you already failed to fulfil all requirements, we can support you with that.
Just answer these 3 questions and we will contact you personally.
In our free consultation call our expert will check with you your current status and discusses with you how Ventum can efficiently and fast
We got you covered
Advantages of our guidance
You can be sure to run through a process that is already proven
You have experts on your side that interact with respective responsible
Extensive reduction of time to market as well as money loss, because you will be guided through a clear path
You can try it yourself, but we got the magic...
Failure to Register
Many companies have failed in their repeated attempts to register with the FDA or MDR-CE. In addition to the reasons of unfamiliarity with the regulations and inadequate preparation of documents, most of them are caused by inadequate preparation of cybersecurity, such as incomplete or no risk management system, and incomplete implementation of security controls.
Attempt Self-Registration
Initially, medical device companies typically attempt to register their products with the FDA or MDR-CE on their own. This process includes risk analysis, product design, document preparation, submission and waiting for review.
Ask Ventum for advice
After many attempts, companies often turn to Ventum for professional help. Ventum fully understands all aspects of the regulatory requirements and will help clients to use existing registration information or materials to complete registration as quickly as possible.
Achieve successful registration
Ventum will provide FDA registration consulting, cybersecurity testing and non-clinical testing services for the entire product lifecycle, particularly in cybersecurity. With Ventum’s assistance, companies are often able to register quickly and successfully. In addition, Ventum can also help you contact clinical sites, communicate with local health insurance access, or set up a local distribution system.
How Ventum supports you
Step by step process
- MDR
- FDA
- Assessment: Ventum assesses your current compliance status and existing registration documentation to perform a gap analysis.
- Customized strategies: We develop a tailored registration strategy to address specific needs.
- Documentation consulting: We analyse the gaps in existing documentation and provide document lists and compliance recommendations.
- Document Review: Our compliance experts will review documents for completeness, relevance, and auditability, provide audit feedback, and assist with revisions.
- Regulatory expertise: Full interpretation of MDR-CE / FDA regulations and compliance reviews.
- Strategy advice: We provide compliance advice that is most appropriate for clients, such as risk.
- Penetration testing: SW, HW, cloud
- Clinical trial suppliers for the US and European Market: Clinical trial suppliers for all CE MDR and FDA medical device classifications in the US and ER markets
- Submission support: Assistance with document preparation and submission, preparation of cybersecurity reports and FDA reports, and assistance with document submission.
- Ongoing communication: We assist you with follow-up communication with the FDA and timely processing of additional content suggested by the FDA.
- Responding to FDA feedback: We prepare responses to FDA inquiries and compiles additional information as required.
- Approval and compliance: We guide you through the final stages of regulatory approval and advises on post-market compliance.