Medical Devices

LabTest can help you establish which safety and performance standards or other secondary standards are essential to sell your Medical Devices in Canada, United States, the European and Worldwide markets.

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Rapid evolution and innovation in Healthcare technology is what allows for more and more lives to be saved or enhanced every day. But before new Medical devices can be brought to market and used in a medical working environment, they must first meet the requirements as set by the local regulations.

This means that it is necessary to determine if a device can perform effectively without causing harm and/or electromagnetic disturbances in its specific operating environment. Products must be tested to the applicable standards of the market (country) they are intended for, to ensure they meet the safety and performance requirements as outlined in the main standard and in the collateral standards (if applicable). Once they do, they get approved.

LabTest is an accredited Certification Body (CB), Testing Laboratory (TL), and Inspection Body (IB) who can assist you in determining which Safety & Performance or other collateral standards are required to sell your Medical Devices to the North American, European, and global markets.  

Our safety experts acknowledge the challenges associated with Safety and Electromagnetic Compatibility (EMC) testing of medical products for global export and therefore, provides manufacturers with 3rd party Testing and Certification, to ensure that a product launch occurs smoothly, in a timely manner, and in the most possible cost-effective way.

Regulatory Requirements for Medical Devices and Systems

Safety & Performance

Safety

Electrical Medical Equipment & Systems are required to comply with the 60601 series of standards for safety and performance. The series is harmonized under the IEC 60601 series. However, a country may have its own national deviations to the IEC standard, for example:
  • CAN/CSA C22.2 NO. 60601-1 – Medical Electrical Equipment – Part 1: standards cover the General Basic Safety and Essential Performance requirements for the North American market.
  • ANSI/AAMI ES60601-1 – Medical electrical equipment-Part 1: General requirements for basic safety and essential performance.
  • EN 60601-1 – Medical electrical equipment. General requirements for basic safety and essential performance.

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Performance (EMC)

In addition to Safety evaluation, Medical Equipment & Systems are also required to comply with product specific standards for Electromagnetic Compatibility (EMC) to IEC 60601-1-2 and/or any applicable country-specific deviations. LabTest provides Emissions and Immunity testing for to national and international standards:

  • CAN/CSA C22.2 NO. 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests (IEC 60601-1-2:2014, fourth edition, 2014-02, with Canadian deviations)
  • ANSI/AAMI/IEC 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
  • EN 60601-1-2 – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests

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Risk Assessment

The 3rd edition of IEC 60601-1, in comparison with the 2nd edition, puts emphasis on the Risk Management file and process conforming to ISO 14971, as well as essential performance.

Application of risk management to medical devices is a mandatory requirement when demonstrating compliance to the IEC 60601 series of standards. Without this documentation, compliance is not possible. LabTest can provide support and guidance on risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments.

Medical devices testing LabTest

CSA SPE-3000

Special Inspections to Model Code CSA SPE 3000 apply to one-time approvals for Medical Electrical Equipment (MEE) and Medical Electrical Systems (MES) that are required to meet Canadian standards. This fast and cost-effective process applies to products that are sold and operated in Canada only. Approved products will be labelled onsite. Read More
During the current COVID-19 global pandemic, remote inspections of Essential Medical Equipment is permitted, to ensure the safety of all involved. Click on the button below to learn more.
SPE-3000 special inspections – Remote Inspections of COVID-19 Essential Equipment

R&D and Start-Ups

Expertise, communication, guidance, and most of all, flexibility are some of the key items that Start-Up companies should look for, when shopping around for a Testing & Certification body. LabTest provides you with all of that and more:

  • Early planning to identify key markets
  • Customized and flexible test plans
  • R&D Testing (PDR program* & Pre-Compliance testing**)
  • Open and clear communication
  • Dedicated technical team of experts to assist and guide you through the process

Make sure to contact us at the very early stages of your Medical Device development, so any potential red flags can be identified early on, to avoid costly and time-consuming bumps in the road later on.

Management Systems Services

Organizations involved in the design, production, installation and servicing of Medical Devices are also required to have ISO 13485 certification, for their Quality Management System (QMS) to ensure the consistent design, development, production, installation, and delivery of medical devices that are approved for their intended purpose. Certification to the standard requires the organization’s QMS to pass a third party Medical Device Single Audit Program, called “MDSAP” Audit.

* Preliminary Design Review (PDR) – Electrical Safety
** Pre-compliance – EMC pre-scans

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