Xeridiem Medical Devices is a premier designer and developer of complex, single use medical devices sold worldwide. By bridging the gap between our clients’ original concepts and commercialization, we facilitate the rapid launch of new products that can become well-established market leaders.

We have achieved significant milestones in our history including:

• Created the first temperature sensing catheter and brought to market the first silicone catheter for treating benign prostatic hyperplasia (BPH)
• Filed more than 90 510ks for over 1,000 different medical products
• Produced more than 22 million medical devices used for patient care worldwide
• Received the Medical Device Excellence and the R&D 100 Awards

Xeridiem’s financial strength, technical expertise, process discipline, and client responsiveness ensure peace of mind to our clients, every step of the way. Our goal is to make life simpler for our customers.

We orchestrate the entire program management process, including:

• Comprehensive design inputs
• Product design and development
• Detailed documentation for US, Canada and EU regulatory approval
• Development of optimized manufacturing processes
• Flexible manufacturing options, packaging, sterilization, and logistics for product launch.

Xeridiem orchestrates exactly what each client requires

     –   to bring a complex, single use medical device to market

     –   bridging the gap between your concept and product commercialization

     –   on time, on budget with no surprises.

For nearly three decades we operated as MRI (Manufacturing & Research, Inc.). In 2011, as we embarked on a strategic growth initiative, we changed our company name to Xeridiem Medical Devices. A subsidiary of the UK-based, multinational Fenner plc, Xeridiem is  certified to or complies with the following:

• ISO 13485:2003, Medical Devices – Quality Management Systems – Requirements for regulatory purposes
• Code of Federal Regulations (CFR) 21 Part 820, as amended, The Quality System Regulation for Medical Devices (QSR), 07 OCT 1996
• Canadian Medical Device Regulation (CMDR), SOR98/282
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD), as amended
• ISO 14971:2007, Medical Devices – Application of Risk Management to Medical Devices