From initial concept to market and everything in between, Pega Medical’s team will guide you through all the steps of product development.

Whether you are a physician with a unique product idea, a start-up company overwhelmed by regulatory requirements or a research center looking to bridge the gap between fundamental research and market ready devices, Pega Medical Services is the partner you are looking for.

Pega Medial Services’ comprehensive approach to product development will streamline your device to the market while meeting performance, design, regulatory and cost requirements.

Since its foundation in 1994, Pega Medical has worked with surgeons from all around the world towards the development of new and innovative medical devices. In some cases, these partnerships have resulted in the development of revolutionary products that have found commercial success across the globe.

Large companies will try to persuade you that your projects are not commercially viable due to the reduced size of the pediatric orthopedics market. We however disagree; a good product idea, targeted to a smaller market, can be of critical value when it is the first one to address an important shortfall, or when it is unique and ground-breaking. The viability of a medical product is also sustained by its patentability, its simplicity of use, and its feasibility in obtaining regulatory clearance (FDA, Health Canada and CE Certification).

As a company dedicated to pediatric orthopedics, we are well versed in dealing with specialized products that target niche markets. With this in mind, Pega Medical will continue focusing on new and improved devices specifically designed and developed for the pediatric patient.

• Do you find yourself wondering why nobody has come up with a certain improvement on an existing device?
• During the course of a surgical procedure, do you ever have a great idea for a product that would simplify your life in the O.R.?
• Most importantly, do you believe children deserve the highest quality products designed specifically for them?

If so, please contact us, we can help make your ideas a reality.

With expertise in the orthopedic, spinal, cardiovascular and dental fields, Pega Medical’s bioengineering services has been offering on-demand engineering to the industry for over 15 years. Our comprehensive approach to product design will accelerate your product development cycle and reduce your time to market.

Our bioengineering services include:

• Integrated design from prototypes to final concept
• Design for manufacturing
• Feasibility and cost analysis
• Finite Element Analysis
• Rapid prototyping

Having access to external engineering resources, in a cost-effective way, will give your company a leading edge in today’s highly competitive market. The development of innovative products with distinct technological advantages is carried out under strict confidentiality and IP agreements. Pega Medical Services will collaborate with you in order to develop strategies, and will function as an extension of your own R&D resources.

If you need to know whether your product meets the national and international regulatory requirements for safety and effectiveness, or how it compares to the competition's products, Pega Medical Services can perform in-vitro biomechanical evaluation of your new product to verify its structural integrity and function, as well as recommend possible modifications. Our technical staff possesses vast expertise in standard and non-standard biomechanical testing, biomaterials' tribology and corrosion, micromotion, fracture mechanics, regulatory issues, and international standards (GMP, AAMI, ANSI, ASTM and ISO for medical devices).

Combining our in-house capabilities to our network of expert facilities we can offer a vast array of bioengineering services including:

• Fatigue and static testing on orthopedic and dental devices
• Physiological and dry testing environments
• Wear testing on device components
• Physical characterization of new biomaterials (porous and non-porous).
• Pre-clinical animal models
• And much more

Regulatory clearance of new medical devices is one of our strengths. Pega Medical Services’ strong technical background, coupled with a solid understanding of US-FDA and Canadian regulatory requirements, has been a key factor in submitting successful pre-market applications. Pega Medical is ISO 13485:2016 and MDSAP certified.

Our regulatory services include:

• US-FDA 510K submissions
• Health Canada Medical Device License (MDL) Applications
• Europe CE Marking
• Expertise in South American regulatory issues

Let us help you navigate the regulatory process and bring your products to market.