Swedish Key2Compliance and Canadian Ironstone Product Development enter partnership

June 1, 2023

Medical device and pharmaceutical consultants Key2Compliance have signed a collaboration agreement with Canadian Ironstone Product Development. The agreement gives Key2Compliance a stronger offering in North America and Ironstone a stronger offering in Europe.

Key2Compliance has several years of solid experience and competence in the European market, both in terms of medical devices, In Vitro Diagnostics, and pharmaceuticals. It is now strengthening its offering on the North American market, by entering a partnership with FDA and Health Canada consulting experts Ironstone Product Development, based out of Toronto Canada. The partnership primarily applies to the medical device segment.

Jan Hellqvist“With Ironstone, we will have an even better reach and competence in both Canada and the USA. We previously had a good knowledge of the American market, but it will now increase enormously. So, above all, this is positive for our customers”, said Jan Hellqvist, CEO from Key2Compliance.

The collaboration means that Key2Compliance gains access to an additional 15 consultants who have extensive experience in working with the American Food and Drug Administration, FDA, as well as the Canadian counterpart, Health Canada. The same applies to Ironstone, which will add a total of 60 European consultants.

“This is a huge boost for the medical device community as we increase the reach and in-house knowledge of both firms. We’re very happy to have started a collaboration with a partner who will give us an even stronger push forward on the European market. Many customers rely on our expertise for navigating the new EU MDR and IVDR, and now we can leverage additional expertise in these areas with Key2Compliance” said Joel Ironstone, President of Ironstone Product Development.

Beyond expanding the expertise offered by both firms, a significant benefit of the partnership is that the two companies will be able to perform audits for each other’s clientele, which will mean greater efficiency for medical device manufacturers working in North America and Europe.

About Key2Compliance
Key2Compliance offers complete and optimized solutions within Regulatory compliance. Key2Compliance are a full-service partner that offers consulting and training for medical devices, In Vitro Diagnostics, and pharmaceutical companies. Key2Compliance area of expertise are medical device QA, pharma QA, clinical development (CRO), biological safety, regulatory affairs and training and courses. Key2Compliance job is to make the complex easier and to help companies interpret and implement the rules effectively to comply with the regulations, while developing a long-term sustainable business. Key2Compliance will help you reach an optimal level of regulatory compliance without investing too much time and resources.

About Ironstone Product Development
Ironstone Product Development (IPD) assists its clients with all aspects of development and commercialization of medical devices and health products. IPD’s team members have successfully commercialized dozens of innovative medical and healthcare products.

These products have changed healthcare and have generated transformative revenue for the companies involved. IPD works with entrepreneurs and established companies to help define the right product and find the most effective way to get it into the hands of doctors and patients who need it.

More information is available at www.key2compliance.com and www.ironstonepd.com

For further information, please contact:

Jan Hellqvist, CEO

Joel Ironstone, President