The full implementation of EU MDR 2017/745 affects every medical device company targeting the European market. The regulations are strict. The documentation is burdensome. To a great number of manufacturers, the thought of a Notified Body audit seems daunting.
However, compliance does not necessitate traveling or costly seminars. Now you have the opportunity to develop the required expertise remotely. MDR Consultants offers a streamlined path to success.
Regulatory preparedness is critical. However, it is uncommon to just read the regulation text. You must know how auditors perceive it. Our audit team comprises ex-auditors of Notified Body and FDA reviewers. We transfer that particular auditor mentality to our learning materials.We assist your team in comprehending complicated requirements, including Articles 10 Quality Management System rules. This knowledge is checked by completing an EU MDR Online Certification. It is a demonstration to the stakeholders that your staff is qualified. It makes all people realize their contribution to the preservation of safety and performance standards.
The knowledge should become action. We are offering operational tools to fill that gap. With our proprietary EU MDR Internal Audit Checklist, it is possible to do a complete gap analysis. It addresses such crucial areas as such as technical documentation according to Annexes II and III.
Confidence is enhanced when using these organized tools in real audits. It assists you in discovering the compliance gaps before they turn into regulatory concerns. You save time by avoiding the need to create assessment criteria from scratch.
The basis is training, although the application may need specific guidance. A qualified Medical Device QMS Consultant is your strategic partner. We do the hard work, such as Clinical Evaluation Reports and Post-Market Surveillance plans. We also assist our professionals in balancing their work. Your EU MDR work with us also assists with the ISO 13485 certification and preparation of the FDA QMSR. This combined system minimizes overlapping work. It conserves resources and shortens your time to market.
Conclusion
Do not allow the complexity of regulation to slow you down. It is possible to sail through the changes with the right support. Give your team skills, training, and powerful tools.
Partner with MDR Consultants and learn more about our EU MDR Online Certification resources and consulting services.
About The Author:
Isabel Osorio is the president and founder of MDR Consultants Inc. , a medical device consulting firm specializing in regulatory and quality consulting services for the medical device industry. She is a former member of industry following a 16-year career in the medical device field, where she gained extensive experience as an Engineer, a Lead Auditor and a Certified Trainer for Notified Bodies, and as a medical device consultant. While working on the front lines as a Clinical Specialist years ago, a chance encounter opened her eyes to the detrimental effects of companies skipping past proper quality controls and procedures.
This experience changed her perspective on the importance of Medical Device Standards and Regulations forever and inspired her to focus her career on helping medical device companies and professionals better understand the requirements to ensure confidence and competence in their implementation of relevant requirements. Product malfunctions can have harmful effects on someone’s life, including death, and that patient could be you or a loved one. That is why patient safety is at the heart of her MDR Consultant’s mission to provide best-in-class training and consulting services. You can reach her at info@mdrconsultants.com
