As a healthcare startup or small-medium sized business (SMB), navigating the medical device certification process can be daunting yet important for business success and growth. While some healthcare startups or SMBs may view certification as a competitive advantage or the next step in their business evolution, others see it as a necessary requirement to meet customer demands for enhanced product quality. Regardless, obtaining the appropriate certification for your medical device or equipment can allow you to access target markets not only in the U.S., Canada, Europe, and Asia but also other worldwide markets.

Key Standards to Consider

As a Nationally Recognized Testing Laboratory (NRTL) accredited by the International Accreditation Service (IAS) for the Occupational Safety and Health Administration (OSHA) and the Standards Council of Canada (SCC), healthcare startups rely on CSA Group to address their testing and certification needs. In addition to our accreditations, our CSA marks are recognized by Authorities Having Jurisdiction (AHJs). Furthermore, our global network of Conformity Assessment Bodies Testing Laboratories (CBTLs) under our National Certification Body (NCB) status allows us to evaluate your products at a location convenient for you.

Through our accreditations, we offer testing and certification against international medical device and laboratory, test and measurement equipment standards, such as:

• IEC 60601/ISO 80601 series – Medical electrical equipment: IEC 60601 and ISO 80601 are a series of international standards that specify safety and performance requirements for medical electrical equipment, confirming their safe use in healthcare settings.
• IEC 61010 series – Safety requirements for electrical equipment for measurement, control, and laboratory use: IEC 61010 series of standards outline safety requirements for electrical equipment used for measurement, control, and laboratory use. It confirms the protection of users and surrounding environments from potential hazards arising from the use of such equipment.

Depending on your medical equipment, you may be subject to demonstrating compliance with specific standards. For instance, CSA Group can provide testing, inspection, and certification services for a range of medical robotics. This could include:

• Electromagnetic Compatibility (EMC) Standards:
  • IEC 60601-1-2
• Process Standards:
  • IEC 60601-1-6 (Usability)
  • IEC 62366, IEC 62366-1 (Usability)
  • IEC 62304 (Software)
  • ISO 14971 (Risk Management)
• Dental Standards:
  • 80601-2-60 (Dental surgical)
  • IEC 60601-2-63 and IEC 60601-2-65 (Medical Electrical Equipment)
• If your medical robots incorporate other types of equipment, additional standards may be applicable:
  • 60601-2-2 (High-Frequency Surgical Equipment)
  • 60601-2-18 (Endoscopic Equipment)
  • 60601-2-22 (Laser Equipment)
  • 60601-1-11 (Robotics for Home Environment)

Testing & Certification Process for Medical Devices and Laboratory, Test and Measurement Equipment

Certification involves an initial independent evaluation of a product (or product prototype) to determine if the medical device or laboratory, test and measurement equipment meets the requirements of the standards specified in the certification documentation.

The process may include testing as well as follow-up inspections to help confirm ongoing compliance with the certification requirements, as established by applicable standards.

In some cases, a certification body may apply its mark to specific products that have passed the necessary evaluations outlined by the applicable standards. In other cases, a manufacturer may be licensed to apply the mark to the products it is producing.

Application for Certification

Testing, Inspection, and Evaluation of The Medical Device or Equipment and Resolution of Any Identified Non-Conformances

Initial Evaluation of The Manufacturing Factory

Evaluation of Drawings, Intended Use, Construction, and Test Results

Documentation and Reporting of The Evaluation

Issuance of the Medical Device or equipment’s Certificate of Compliance

Delivery of Documentation to The Manufacturer

Follow-Up Surveillance and Factory Audits

We assist you through the medical device and laboratory, test and measurement equipment compliance journey by providing expert testing and certification solutions for a wide range of medical equipment.

The CSA mark is recognized globally, giving you access to target markets worldwide.

As a healthcare startup, obtaining medical and laboratory, test and measurement equipment certification with the internationally recognized CSA mark can help facilitate your entry into markets worldwide. The CSA mark serves as an indicator that your healthcare solutions have successfully met applicable regulatory requirements, including but not limited to safety, performance, and energy efficiency criteria.

Commonly Recognized CSA Group Certification Marks:

For more information about CSA Group’s certification marks, click here

Seize global market opportunities by leveraging the knowledge and networks of international certification experts.

You can leverage the opportunities of global markets by tapping into our network of international certification experts. Our Global Market Access team is equipped to help you take advantage of today’s global economy, supporting you as a centralized service provider to help you navigate local and international requirements and access target markets.

Uncover the benefits of collaborating with our Global Market Access team by clicking here

Medical and Laboratory, Test and Measurement Equipment Compliance Starts with the Design

The certification journey for your medical device and laboratory, test and measurement equipment with CSA Group does not need to start solely at the product evaluation or approval stage. Whether you are conceptualizing a new healthcare solution or modifying an existing one, CSA Group can help you navigate and understand essential requirements during the design stage.

Our pre-certification Technical Information Service aims to support you early in the product lifecycle — as early as the product design phase and before you commit production — helping you avoid potential costly revisions and helping facilitate a seamless certification process.

Click here to learn more about how our Technical Information Service.

Why leverage our expertise?
Committed: We consistently deliver on our service promises. Our dedication over the past 100 years has transformed the CSA mark into one of the most sought-after proofs of compliance in the market.

Swift: We help accelerate time to market by identifying the most efficient solutions for your needs. This involves explaining compliance requirements from the early design phase to maintaining collaboration throughout the certification process.

Accurate: We help minimize risks by providing a clear, detailed scope of work from the initial stage. This approach is designed to help your product achieve successful testing results the first time.