Assessment and regulatory filing in the USA, Europe, and Canada.
International standards, including ISO 13485, CMDCAS, and FDA QSR.
All phases of feasibility and methodology design.
& Market Appraisals
Projects including wearables, medical device, and health technology.
Ironstone Product Development (IPD) assists its clients with all aspects of medical device and health product development and commercialization. Our team members have successfully commercialized dozens of innovative medical and healthcare products.
These products have changed the practice of healthcare and have generated transformative revenue for the companies involved. We work with entrepreneurs and established companies to help define the right product and find the most efficient way to get it in the hands of the clinicians and patients that need it.
We cover everything from pre-submission and classification of your product (Class II vs. De-Novo vs. Class III), to regulatory submissions. We have drafted dozens of successful submissions across several therapeutic areas.
Our services include technical file and design dossier preparation, clinical evaluations, and post market surveillance to meet all European regulations.
Canada is an excellent location to conduct clinical studies, ranging from first-in-man to multi-center pivotal trials. We can take your project through pre-submission engagement, to Investigational Testing Authorization (ITA) preparation, to licence applications (Class II-IV).