At MDR Consultants Inc., we employ some of the finest medical device industry experts. Our team is full of consultants with years of hands-on experience in pretty much every aspect of setting up and maintaining quality management systems in medical device manufacturing plants. The new EU Medical Device Regulations are forcing several manufacturers to re-think their approaches to medical device manufacturing. MDR Consultants Inc. is here to help companies become fully prepared for these upcoming regulations.

Lead by Isabel Osorio, a master of Science in Biomedical Engineering, MDR Consultants Inc. has been able to help hundreds of medical device manufacturers technologically improve their production processes. From making the products safer for consumer use to creating sustainable manufacturing procedures – our Medical Device Consulting Services help our clients obtain tangible improvements. If your company wants to produce products that will consistently meet all government guidelines and requirements, MDR Consultants Inc. can help you achieve this dream.

Experience, Professionalism, and In-Depth Industry Knowledge Everyone working at MDR Consultants Inc. has years of experience in QA/RA management positions. These experts can help you assess, evaluate, document, and implement relevant changes to your Quality Management Systems. We live and breathe regulations. We’re always up to date about the latest requirements government bodies levy on medical device manufacturers.

• Our Internal and Vendor Audits are carried out by highly experienced Medical Device Internal Audit Consultants. These experts can help you with software and validation testing, implementation of policy and procedural controls, and meet strict quality standards.

• We educate our clients’ employees about the latest FDA, EU MDR, and ISO regulations that directly impact the devices they manufacture.

• We are currently offering a new two-day Medical Device Online Course on the latest European Union Medical Device Regulations.

Since learning all new rules/regulations can be time-consuming for medical device manufacturers, MDR Consultants Inc.’s experts take on this responsibility on their behalf. Sign up for our Medical Device Single Audit Program if you seek speedy approvals from various regulatory agencies. More importantly, medical device manufacturers become more responsible with their strategy developments, product registrations, and other duties after partnering with us.

Contact details:

• Name: MDR Consultants Inc.
• Website: www.mdrconsultants.com
• Phone: (786) 306-0227
• Address: 11111 Biscayne Blvd. Miami, Florida, 33181
• Email: [email protected]