BaxMed Regulatory Ltd Avis 4

We contacted Baxmed when we needed to bring an obsoleted product back to market under the EU MDR in time for a contract submission. Baxmed clearly outlined the required details, addressed any potential compliance issues early, collected the necessary data and immediately got to work. The technical file they produced was clear, well structured and enabled us to place the product on the market in time for the contract deadline.

In addition, we had fallen behind with our PMS schedule and needed support to update a range of documents in time for our ISO 13485 / UK MDR audit. Baxmed confirmed this was an area they could help support. After discussing the updated UK MDR PMS requirements, we assigned multiple product ranges to them. Despite receiving data in a difficult format, the PMS reports they produced were clear, professional, and audit-ready.

A special shoutout to Niki and Jay, who were pivotal in delivering both of the projects in time for our deadlines. They went above and beyond to help out with closing off key stages of the projects and we would not have been able to achieve our targets without their support!

We will be keeping Baxmed in mind as a key resource when future projects come up and we will be very happy to work with them again.

I worked with the BaxMed team as a consultant, working with them on the implementation of an ISO 13485 QMS. BaxMed is built on the foundation of their people, their knowledge, expertise and openness has made them into a strong team of Quality and Regulatory experts.
I would highly recommend BaxMed to any business looking for high level quality and regulatory expertise that will work alongside their partners in a friendly and professional manner while delivering exceptional results.

We first met with BaxMed at MedTech Expo and found their knowledge of Quality Assurance and Regulatory Affairs to be invaluable. The team at BaxMed have spent time to really got to know me, my product and my project and have taken away all the stress and anxiety. Their approach is really modern, and their knowledge and level of expertise is unrivalled.

To top it off they are good people who listen, care and give solid advice based on what you want to achieve. Stuart and the team made me appreciate and actually enjoy the regulatory side of the business. I'll be working with them next year to continue my compliance journey.

I engaged Baxmed Regulatory Ltd to support our regulatory and quality requirements based on extremely positive feedback from a trusted colleague, the experience has been exceptional. Their warmth, professionalism, expertise and proven ability to deliver to our needs in a manner which feels like them being part of the broader committed team have been pivotal to the success and position to date
Key Highlights of Our Collaboration:
1. Comprehensive Regulatory Expertise
2. Efficient Quality Management System (QMS) Implementation (ISO 13485 and 21 CFR Part 820) with scalability for future eQMS enablement
3. Streamlined Documentation and Processes
4. Proactive Communication and Training

Results Achieved:
• Efficient onboarding of authorised representatives for multiple countries/regions
• Enhanced QMS compliance and readiness for audits
• Improved team knowledge and confidence in regulatory processes
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Summary:
Baxmed Regulatory Ltd have been invaluable team members/partners, offering the perfect blend of technical expertise, strategic insight and personalised service. I highly recommend their services to any organisation seeking top-end support for your regulatory and quality management opportunities