Tangent Design Engineering Ltd. (Tangent) is a full-service design engineering firm, providing core expertise in mechanical design and product development. The two major business areas they focus on are specialized industrial equipment and precision instrumentation and medical devices. Their scope of services includes electromechanical system design, mechanical stress analysis, fluid flow modeling, regulatory and product compliance management, as well as testing and certification.
Tangent is based in Calgary, Alberta and has been providing engineering support and product development services to a wide variety of industries since 2005. We have experience in the following sectors:
- Manufacturing and Process Equipment
- Oil & Gas Equipment (Surface, Drilling and Down-Hole)
- Industrial Devices
- Consumer Products
- Medical Technologies
Tangent has the ability to meet your mechanical and electrical design needs from concept to simulation to prototype. They are qualified engineers and senior industry experts who can also provide sound advice and services in analysis & simulation, product commercialization, fabrication, project management, software design, PCB design, product compliance, prototype creation and testing.
Tangent was established in 2005 with 2 directors and 1 employee, and has grown to 16 full time staff. They are currently in the process of hiring more staff and moving into a larger office space.
Tangent has regulatory certification
Tangent has recognized the need to standardize their design process and decided to focus on International Standards Organisation (ISO) quality management system (QMS) as a recognized certification. Health Canada and the FDA require evidence of a quality management system to ISO 13485 standards. Any device developed outside those standards would be rejected at the application stage and leave companies scrambling to build a design history file, which could go back for years. Tangent wants to make sure their clients receive a complete package ready to submit, which is why they acquired these certifications.
See more information on Health Canada requirements
Lesson’s learned in ISO13485 certification- one year later
Since they were working with medical devices, Tangent opted to work towards the more challenging rating of ISO 13485:2003, which is a specific additional rating of the more well-known ISO 9001 quality management system certification. The 13485 standard “specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.” (www.iso.org). It took 2 years to build up the quality management system internally before they were ready to approach a certified third party auditor. The auditor completed a readiness audit and gave them an additional 6 months to address additional areas required to include or enhance to meet the standard. Once that pre-audit period was cleared, in September 2013 Tangent had their first complete audit. It took 3 days, but they were awarded both the ISO 13485 and ISO 9001 certifications. It’s not a done deal at this point either; they have to have a maintenance audit every year to show continuous improvement and ongoing compliance with the standards. They just completed their first full year maintenance audit in September 2014. “We are looking forward to continued improvement to provide best in class service for our clients. We’re proud to be recognized as a unique full service design engineering firm in Alberta with ISO 13485 certification for medical device development.” says John Person, VP of Tangent.
The important lesson learned is that the ISO system works best if it’s ‘your’ quality system. There are rules and concepts that have to be covered for certification purposes, but you can’t put an external ISO template to your company culture and work methodologies and hope it sticks. If it starts from internal team interest to standardize and succeed, the system will grow and mature naturally with the business.