Performance Medical Devices
Richmond, BC
Company Overview
Performance Medical Devices is a Canadian-owned and operated medical device manufacturing company that excels in quality and innovation. We develop and manufacture implantable products for cardiovascular repair procedures and lung surgery. Our products, the PeriPatchTM Sheet and the StepSaverTM Cylinder are made from biological tissue derived from cows. We also offer contract manufacturing services to other medical device companies looking to increase their current production capacity or simply to get their medical devices to market quickly and cost-effectively.
The PMD team includes experts in medical design, research and development, engineering, electronics, manufacturing, international sales and marketing, regulatory affairs, quality systems and quality control.
Our technicians have expertise in production and testing of catheters, heart valves, stents, and diagnostic kits, as well as working with a variety of other surgical and electronic devices. Some of our additional capabilities include packaging validation, labelling, logistics management, and materials/warehouse management.
Our involvement in contract manufacturing began about five years ago, when U. S.-based companies began approaching us. Here's why...
- Product to Market Faster. Devices which are end-assembled
and packaged in Canada are not governed by U. S. Patent Law. In addition, medical devices exclusively made for export do not require any regulatory approval or registration in Canada.
- Certification in Quality System. PMD operates according to
the FDA Good Manufacturing Practices (GMP) for medical devices. The PMD facility is ISO 9001 certified and all our products manufactured in our facility are CE approved.
- Saving Time and Money. The exchange rate on the Canadian
dollar means U. S. companies can save money.
Company Information
Physical Address
2135-13700 Mayfield Pl.
Richmond, BC V6V 2E4
CA
Mailing Address
2135-13700 Mayfield Pl.
Richmond, BC V6V 2E4
CA
Additional Details
Legal Name: PM Devices Inc.
Number of Employees: 10
CA
Equipment: Instron Pull Tester, Alloyd Tray Sealer, Doboy Pouch Sealer, Dissecting Microscopes, Compressed Air/Nitrogen Sources in Cleanroom Equipment, Exhaust Vacuum within Cleanroom Environment
Engineering: CNC Machining, CAD Drawings, Validation, Tooling Design, Project Management, Design Control
Capabilities: Sterilization, Sterility Testing, Import & Export Requirements, Inventory Management, Warehousing
As a result of Performance Medical Devices rapid growth, both with our own product sales and with contract manufacturing, we have recently expanded our facility which includes a state-of- the-art class 10, 000 cleanroom available for new contract manufacturing clients.
Contacts
Paul Geyer
Title: Chairman
Area of Responsibility: Management Executive
Phone: Show phone
Fax: Show fax
Email: Show email
Mary Leliveld
Title: Marketing & Sales Manager
Area of Responsibility: Domestic Sales & Marketing, Export Sales & Marketing
Phone: Show phone
Fax: Show fax
Email: Show email
Carlos Vonderwalde
Title: President
Area of Responsibility: Management Executive
Phone: Show phone
Fax: Show fax
Email: Show email
Mark Pace-floridia
Title: Research & Development Manager
Area of Responsibility: Research/Development/Engineering
Phone: Show phone
Fax: Show fax
Email: Show email
Services
-
Contract Development And Manufacturing
Performance Medical Devices provides contract development and manufacturing services to medical device companies that need to get their high-quality medical products to markets around the world quickly and cost-effectively.
PMD technicians have expertise in the manufacture of permanent implantable medical devices such as artificial heart valves, catheter production and testing, diagnostic kits, drug delivery systems and small medical electronic devices. Additional capabilities include validations, final assembly, packaging and labelling, shipping, logistics management and materials and warehouse management.
PMDs state-of-the-art facility has cleanroom space ranging from Class 1, 000 Class 10, 000. Manufacturing in Canada can save time, money and effort, while ensuring highest quality standards.
Products
-
Hexacath Helistent Coronary Stent
PMD is the exclusive Canadian distributor of the Helistent Coronary Stent. Developed using the most advanced technical simulators, the Helistent's helicoidal structure is recognized as one of the best today. Based on a tubular structure for an improved radial crushing resistance, the Helistent has unrivalled flexibility while maintaining the intrinsic crossability of its carrier balloon. The Helistent's exclusive design plays a decisive role in its superior conformability, making it particularly well adapted for lesions situated in curved arteries. A low deployment pressure means reduced endothelium aggressivity and less risk of dissection. The rigorous quality requirements at each stage of production provide the highest level of safety and security for both the physician and patient.
- Peripatchtm Sheet
-
Stepsavertm Cylinder
Performance Medical Devices develops and manufactures implantable products for lung surgery. The StepSaverTM Cylinder is made from biological tissue derived from cows. The StepSaverTM Cylinder is designed for use in conjunction with surgical staplers, and acts as a staple line reinforcement for lung volume reduction. Cutting-edge design makes this the ultimate device for staple line reinforcement in lung volume reduction surgery. Pericardial cylinders have been shown clinically to reduce complications and length of hospital stays.
NAICS Categories
Additional Information
339110