Medical Device Consulting Services

Professional Medical Device Consulting Services


MDR Consultants provides industry-leading medical device consulting services and training courses that are designed to ensure your company’s Quality Management Systems continuously meet all relevant regulatory and statutory requirements and most importantly, that your products are safe. We guide you through implementing effective solutions for achieving your business goals while establishing lasting trust.


If you need help bringing your medical device idea from concept to reality, MDR Consultants can help. We will guide your company through each step of designing and developing products that meet international standards and regulations so you can get your products on your targeted market sooner, without any hitches along the way that can cause lengthy delays that impact your bottom line.


We offer a wide range of services that will help your company navigate the complexities involved with medical devices. Our team has decades of experience in all stages from design through approval, manufacturing, and post-market requirements so you can feel confident in your approach to achieving compliance and conformance every step of the way.


MDR Consultants offers a FREE comprehensive consultation on how to best execute an effective strategy for your business goals.



Medical Device Quality Management Systems

Medical Devices Quality Management System Services from your Experts at MDR Consultants


An effective Quality Management System that ensures compliance and supports resilience is the foundation for a quality-driven culture. Therefore, it is fundamental to ensuring your organization’s success.


MDR Consultants specialize in the generation, implementation, auditing, and remediation of medical device Quality Management Systems. Our firsthand experience can certainly help you succeed.


Whether you are a one-person start-up or a multi-facility global medical device company, we have the expertise to provide assistance and support.


Book a FREE consultation today.


FDA Quality and Risk Management Systems

Medical Device Risk Management Consulting Services


Risk management is the foundation on which our systems, processes, and products are built.


As engineers, we understand that the effective implementation of a robust risk management system plays a key role in ensuring your products work as intended.


The Risk Management Process is especially important under regulatory requirements because its use, implementation, and outputs provide the means for demonstration that your products and services are safe and effective, they perform as intended, and that their benefits far outweigh their inherent risks.


Our medical device consultants are experts on Risk Management processes and their related statutory and regulatory requirements.


Book a FREE consultation today.


Special Projects

Expert Consultants You can Trust


MDR Consultants strives to provide you with proven, trusted, and cost-effective solutions.


Our consultants have years of experience working for Notified Bodies and leading medical device companies that implement these practices; this knowledge allow us to offer you solutions tailored specifically to your needs while ensuring compliance and conformance with applicable standards and regulations and at the same time, increasing efficiency and effectiveness of your organization that will certainly reduce your costs.


MDR Consultants can support a wide array of medical device related needs, including but not limited to:

  • Training
  • QMS transition to the EU MDR, MDSAP, or UKMDR
  • Implementation of ISO 13485:2016
  • Implementation of ISO 14971:2019
  • Gap Analysis
  • Design and Development of products from idea to market
  • Risk Management
  • Quality Management System Procedure(s) Generation
  • Pre-market Submissions and Licensing (PMA, 510k, Registration, EUDAMED, MHRA, etc.))
  • Technical File Generation and Maintenance
  • Clinical Evaluations
  • Post Market Surveillance
  • Vigilance
  • Remediation Projects or Initiatives
  • 483 Response



Book a FREE consultation today

and let us discuss your needs and the ways we can help you achieve your goals.



Unlock Your Potential with MDR Consultants’ Tailored Training Programs

Are you looking to improve your knowledge and skills in the medical device industry? At MDR Consultants, we offer comprehensive training programs that are designed with your success in mind. Our team of experienced professionals, who have a background as engineers, lead auditors and certified trainers, have a wealth of knowledge and expertise to share with you.


Our courses are crafted to provide a practical and engaging learning experience, ensuring you walk away with a deep understanding of the material. We bridge the gap between the “Why” and “How” of medical device regulations and provide clear, concise guidance for navigating the statutory and regulatory landscape.


We offer a range of options to suit your learning style, from self-paced online courses to live online trainings, as well as custom solutions for companies looking to train their entire staff. Our programs are designed to provide you with the knowledge, clarity and confidence you need to succeed in your role and drive your career forward.


Join the ranks of medical device professionals who have transformed their careers through our training programs. Book your spot today and start unlocking your potential!


We offer both self-paced and live online trainings, as well as custom solutions for companies looking to bring an MDR Consultant in to train their entire staff.


Click here for more information on our current course offering or book a FREE consultation with us today to discuss your needs.

Internal and Vendor Audits

Elevate Your Internal Audit Process with MDR Consultants

At MDR Consultants, we believe that internal audits are the cornerstone of a successful Medical Device Quality Management System. That’s why we offer unparalleled support for internal and vendor audits that can help you meet and exceed all applicable requirements. Our team of certified and qualified former Lead Medical Device auditors of Notified Bodies bring a wealth of knowledge and experience to the table, giving you an inside look at the assessment process and a roadmap to success.


We understand that the internal audit process can be overwhelming, and that’s why we’re here to help. Our goal is to streamline your audit process, making it more efficient, effective, and transparent. Whether you need to outsource your internal audit process, prepare staff for an upcoming third-party audit, or outsource your audits to support your vendor monitoring activities, your MDR Consultant will be there every step of the way.


We’ll work with you to ensure that your Quality Management System meets and exceeds all applicable requirements, so you can have peace of mind knowing that it will withstand third-party scrutiny. Our expert consultants can provide best-in-class training and assessments on the medical device internal or vendor audit process, requirements, effective implementation, and preparation against notified body assessments. The end result? An audit process that is as smooth and stress-free as possible, and a Quality Management System that is prepared to withstand the scrutiny of any regulatory body.


Don’t let internal audits get the best of you. Book a FREE consultation with MDR Consultants today and start elevating your internal audit process to new heights.



Quality Management System

Mastering Medical Device Regulations with MDR Consultants


Quality Management Systems are the backbone of a successful medical device company, and at MDR Consultants, we’re experts in helping businesses achieve their goals. Our team of seasoned consultants have years of experience working with Notified Bodies and leading medical device companies, giving us a unique understanding of the industry and the ability to offer tailored solutions for your specific needs.

We understand that navigating the complex regulations and standards in the medical device industry can be overwhelming. That’s why we’re here to help. From documentation maintenance to monitoring and improvement, we provide cost-effective solutions based on proven and trusted methods that ensure compliance and conformance with applicable standards and regulations. Our goal is to streamline your processes and help your organization run more efficiently, ultimately reducing costs and increasing your chances of success.

At MDR Consultants, we’re passionate about delivering results and empowering medical device professionals with the tools they need to succeed. Our courses are designed to meet the needs of industry professionals and our team of certified trainers provide training programs that are engaging and impactful. Let us help you take your Quality Management System to the next level.


Book a FREE consultation with us today and see how we can help you reach your goals.