Welcome to Medical Device Software and Sterilisation Professionals
Vous aider a être en conformité avec le nouveau réglement MDR
Chez MDSSPRO, nous nous engageons à aider les fabricants et distributeurs de dispositifs médicaux à comprendre, gérer et mettre en œuvre le Règlement sur les dispositifs médicaux (RDM) avec clarté et confiance.
Nos experts en matière de reglementation des dispositifs medicaux proposent des formations, des audits et des services adaptés pour répondre aux exigences de votre système de gestion de la qualité conforme à la norme ISO 13485:2016 et pour vous aider à satisfaire aux exigences du reglement anglais UK MDR 2002, du nouveau règlement MDR 2017/745 et des normes connexes.
Que vous souhaitiez participer à des formations pratiques sur site ou privilégier la commodité des formations virtuelles animées par un formateur, MDSSPRO possède l'expérience et les connaissances nécessaires pour vous aider à maintenir votre marquage CE et vous permettre d’être en conformité avec toutes vos obligations réglementaires.
What Do We Do?
Des services complets de formation et d’audit suivant le RDM
Tailored MDR Training
Our training sessions can be developed specifically to your company's size, product, and regulatory requirements.
Expert Internal Audits
With over 20 years of experience, our qualified internal auditors carry out high-quality internal audits and supplier audits, providing another level of assurance in meeting your regulatory requirements.
Online & On-Site Learning
We recognise that every business, large and small, has specific training needs.
Who We Are
Experiences in Medical Device Regulation, Training and Compliance
Founded by Patricia Vest, MDSSPRO draws from decades of collective experience in medical device regulation, quality assurance and compliance management.
We aim to help navigate the complex world of MDR and ISO standards by providing professional, practical and affordable training and auditing services.
Our Industry Expertise
Over 20 years of regulatory auditing experience. A proven track record of supporting manufacturers to achieve CE certification
Our specialist expertise
Depth of knowledge in software validation, sterilisation, electrical safety and microbiology.
“With MDSSPRO, you gain more than a service provider; you gain a partner in your success, compliance and confidence.”
Our Services
Professional Training, Auditing, and Compliance Assistance for Medical Device Regulation.
At MDSSPRO, we offer a full range of training and auditing services for all aspects of medical device regulation and quality management:
Risk management training
One-day training course covering the basics of EN ISO 14971 and how to use it.
Software requirements training
A 1.5-day course providing an overview of the main aspects of IEC 62304 that relate to medical device software compliance.
Usability requirements training
A 1-day training session looking at IEC 62366 and how it relates to medical devices that are easy to use and safe.
Sterilisation by EO training
Know the requirements of EN ISO 11135 related to the sterile medical devices
Our Commitment to You
Committed to Excellence, Integrity, Compliance
At MDSSPRO, we are committed to supporting our clients through clear, practical, and dependable regulatory support.
Our focus consists of the following to deliver regulatory support:
- Delivering accurate and transparent training
- Delivering real-world applications suitable for your organisation
- Maintaining client satisfaction and continual improvement
Our proven methods and plan to update courses whenever applicable or possible, ensure training is clear, describes expectations, and provides value.
As part of the MAG group, our trainers have over 20 years of experience in training medical device regulators, developers, and application disciplines. We believe in developing a relationship where you want us back to support compliance in your organisation!
Happy Students
Training Courses
What Our Clients Say
Real Experiences, Real Results
At MDSSPRO, we embrace that our clients trust us and we are proud to be able to deliver measurable results. Here is what they have said:
Always Here for You
Your Journey Starts with Us
At MDSSPRO, we use our technical expertise and personal touch, ensuring that every client receives personalised support, timely responses and trusted and reliable advice for long-term success.
+44 7956789289
admin@mdsspro.com
Basepoint Aerodrome Rd, Gosport PO13 0FQ United Kingdom
Send Us Your Enquiry
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Our Methodology:
A Proven Four-Step Process for MDR Compliance
At MDSSPRO, we follow a clear and proven methodology that ensures every client achieves practical, lasting MDR compliance — from understanding regulations to full implementation.
1.
Assess
We assess your existing systems, capturing the strengths and the weaknesses.
2.
Create a Plan
Our specialists develop a transparent roadmap based on your organisation's compliance needs.
3.
Implement
We provide structured training and support to streamline your staff's work towards meeting MDR compliance requirements.
4.
Review
Your business is monitored regularly to check performance towards compliance readiness certification audits.
Our Blogs
Insights and Expertise From Inside the Medical Device Regulation
Stay on top of the most recent topics, expert viewpoints, and insights in Medical Device Regulation (MDR). Read our articles to have a stronger compliance knowledge base and to keep informed.
Mastering Sterilisation by Steam: The Importance of EN ISO 17665-1 Training for Medical Device Professionals
Mastering Sterilisation by Steam: The Importance of EN ISO 17665-1 Training for Medical Device Professionals In medical device manufacturing, sterilisation is one of the most important processes. The expectation for manufacturers is that products presented…
Let's Build Compliance Confidence Together
Partner with MDSSPRO to help ensure your medical devices are safe, effective and fully compliant. From tailored training to expert auditing, we are here to help you every step of the way on your journey to full MDR compliance.
The course on risk management was incredibly well structured and easy to follow. The trainer explained complex ISO standards with real-world examples, making it simple to understand and apply. Highly recommend MDSSPRO for anyone working