Toby Orthopaedics

by | Mar 11, 2024 | TobyOrtho

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Across the ocean: IMed Consultancy supports Miami-based Toby Orthopaedics – 

Toby Orthopeadics a leading provider of innovative movement solutions worldwide, prioritizes enhancing wellness and improving the quality of life for patients, with go-to products for surgeons that keep Toby Ortho at the forefront of the healthcare design community.

Toby Orthopaedics first reached out to IMed Consultancy in 2022 as they needed a new UK Responsible Person (UKRP). Prior to this, their UK distributor, held the UKRP role, presenting a potential conflict of interest. Recognizing the necessity to separate the roles, the distributor recommended IMed Consultancy to Toby Ortho.

A year later, Toby Ortho urgently needed a new regulatory consultant to prepare for an upcoming audit. Having worked with IMed successfully before, they once again reached out to the IMed team, relying on their support with all things regulatory.

Gina M. De La Pava, Operations Manager at Toby Orthopaedics, explains: “I have no regulatory background, but one of my main goals when hiring a regulatory consultant was to achieve independence and confidence in dealing with regulatory matters. I was pleasantly surprised to find that IMed’s approach perfectly aligned with this goal, confirming that I made the right choice.”

IMed’s support extended beyond the audit preparation, taking on tasks such as ensuring compliance with Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), Clinical Evaluation and Quality Management System (QMS) documentation.

Through their collaboration with IMed Consultancy, Toby Ortho not only addressed immediate regulatory needs but also gained the confidence and expertise necessary to navigate regulatory challenges independently, now relying on IMed only when needed, and to make sure everything’s in order.

“They’re extremely knowledgeable, and they involved me in all processes right from the start, making sure I had a basic understanding of regulations and compliance. I particularly appreciated their “can-do” attitude: even with limited time, they doubled down and made sure everything was ready on time.” Continues De La Pava.

“Working with Toby Orthopaedics has been – and still is – a pleasure. Their products are truly state-of-the-art and we’re honoured to be able to support them in this journey.” says Matthew Burton, IMed’s Strategic Development Director, that worked closely with Toby Ortho. “We were short on time and the time difference did not help, but one thing we love at IMed is a challenge!” continues Burton.

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