Clients & Partners
We work with some of Canada and the world’s most exciting medical device companies, including:
“We developed a great partnership with Ironstone Product Development over the past 3 years in regulatory, quality, clinical and manufacturing aspects of our medical device to achieve important milestones. Their expertise and dedication to our small business growth is profound and their methodical approach continues to provide reliable and timely expertise at our finger tips. We could not have done this without you! Thank you Joel, Abhi, Martin and the team for your unrelentless support! Looking forward to the next chapters!”
– Chantal Lainesse, Chief Scientific Officer of SterileCare Inc.
“It was an absolute pleasure to work with Martin and the team at IPD on our ISO certification and quality management system development process. Beyond being extremely knowledgeable and professional, they took the effort to ensure that the approach being taken to helping develop our quality management system was bespoke to our needs and contextually appropriate to our business!”
– Puneet Seth, CEO of InputHealth
“Joel and his team at IPD have been crucial partners in our recent success here at MolecuLight. We initially engaged IPD to salvage our FDA submission, which had been stalled in long and challenging regulatory negotiations. IPD was willing to do whatever it took to get the submission through — from working with our engineers to develop appropriate test methodologies to astutely negotiating with the FDA on our behalf. The ROI from their efforts exceeded our expectations: Shortly after engaging IPD, our MolecuLight i:X product achieved De Novo clearance as the world’s first portable wound fluorescence device. Immediately building upon that success, the IPD team designed and planned a key practice-changing clinical study and worked with their biostatistician to receive FDA agreement on its adequacy, allowing us to expand our indications for our MolecuLight i:X device.
We are grateful to continue working hand in hand with the IPD team. Their capability and willingness to dive deep into understanding the technology, science, and clinical details of our products has made them an invaluable partner to MolecuLight, whether it be for regulatory, clinical, quality, or product development support.”
– Anil Amlani, CEO of MolecuLight Inc.
“IPD has successfully led Mariner through the process of getting our first product to market. Their team created our business, regulatory, and product development plans, managing our path to receiving FDA clearance in record time. Their technical experts designed key system components of surgical augmentation device, including the rigid tracking bodies, hardware, and software of our surgical augmentation device.
“They developed our ISO 13485:2016 and FDA QSR-compliant Quality Management System (QMS), authored critical design documents, executed human factors testing, and directed our internal and external verification and validation testing en route to authoring our 510(k) premarket notification application.
“From start to finish, we obtained FDA clearance in 18 months, including record time for approval of 77 days from submission. IPD’s team of regulatory, clinical, product development, and quality experts have been integral to all of Mariner’s achievements.”
– Mitch Wilson, COO & President of Mariner Endosurgery
“Joel and his team worked with us from conceiving of the product and business strategy to a successful exit to a large multinational. They acted as far more than than subcontractors and provided significant mentorship and guidance through the ups and downs of developing our first product. IPD provided critical support in engineering, clinical trial design, and regulatory compliance. In each area their deep expertise and experience moved our project along much faster than it would have otherwise. I attribute a significant amount of success to their support and look forward to working with them on my next endeavor.”
– Tim Ahong, Founder & CTO of Sensassure (Acquired by Essity AB)