If you need to know whether your product meets the national and international regulatory requirements of safety and effectiveness, or how it compares to the competition's products, Pega Medical will perform in-vitro biomechanical evaluation of your new product to verify its structural integrity and function, as well as make recommendations for any modifications. Our technical staff possesses vast expertise on standard and non-standard biomechanical testing, biomaterials' tribology and corrosion, micromotion, fracture mechanics, regulatory issues, and standards (GMP, AAMI, ANSI, ASTM and ISO for medical devices) · Wear testing on device components (metal-on-metal-, PEEK, UHMWPE, YTZP, etc.) · Physiological and dry test environments · Fatigue and static tests on dental and orthopedic devices · Physical characterization of new biomaterials (porous and non-porous). Regulatory clearance of new medical devices is one of our strengths. Pega's strong technical background coupled with a solid understanding of US-FDA and Canadian TPP has been a key factor in submitting successful pre-market applications

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US-FDA 510K, PMA and IDE submissions   Health Canada Device License Applications   Expertise in South American regulatory issues

The development of innovative products with distinct technological advantages is carried out on demand. Under strict confidentiality and IP agreements, Pega Medical will collaborate with you in order to develop strategies and will function as an actual extension of your own R&D resources.

Typical projects:

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Development and optimization of surgical instrumentation    Development and management of research protocols and projects    Development of spinal machined allografts    Development of instrumentation for cardiovascular surgery

Pega Medical is actively involved in the development of the Latin-American Market with new services and its own line of products. The company is working with both North and South American companies to establish new joint ventures. Due to its comprehensive network of contacts, Pega Medical can help your company to establish commercial relations with European, North American and South American OEM's for distribution or licensing of novel medical devices. Close ties with university-based groups and hospitals through collaborative research allows the company to have access to new technologies in the areas of Maxillofacial Reconstruction, Dental Implantology, Biological Coatings, Orthopedic Surgery and Biomaterials. Pega Medical currently owns a percentage of the intellectual property for several new patent-protected products at an advanced stage of development and it is open to establishing new alliances to bring those products to the market.

Some examples are:

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Fassier-Duval Telescopic Intramedullary Nail for the treatment of Osteogenesis Imperfecta   OsteoDisc for autologous hard tissue reconstruction commercialised by Citagenix Inc.   Maxillofacial devices for trauma and distraction osteogenesis   New dental implant   Spinal Fixation Devices

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