IEC 60601

IEC 60601 Consultancy & Training

Lorit Consultancy’s team has years of experience in the implementation and application of the IEC 60601 series of standards for safety requirements for medical electrical (ME) equipment and systems.

Whether you need consulting, support or training – we support your team with our expertise in safe product design.

 

Why is the IEC 60601 standard of great importance?

Basic safety and essential performance of ME equipment and ME systems are fundamental requirements for medical devices to minimise the likelihood of harm during their use. These requirements range from correct classification and protection against hazards to safe design.

The IEC 60601-1 standard is a prerequisite for the market introduction of medical devices in many countries. Therefore, a clear understanding of the standard is crucial in the development of ME devices and systems.

 

IEC 60601 Relation to other standards

For the launch of products in global markets, a comprehensive understanding of the regulatory landscape is required, i.e. which standards or international directives may influence the requirements of IEC 60601-1.

IEC 60601-1 is primarily focused on device safety and is strongly linked to ISO 14971. Risks can be very diverse and take into account many different factors that require broad expertise.

 

Our services

Consultancy & Support:

  • Risk analysis, FTA, HAZOP, STPA & FMEA
  • Hardware and software reviews
  • Preliminary hazardous analysis
  • Usability reviews and analysis
  • Cybersecurity analysis
  • Definition risk control mechanism

Training:

We offer (online) training course that can be customised to meet your requirements in terms of date, schedule and content.

In our IEC 60601 Introductory or Advanced courses you learn the basics or implementation and application of the standard with work examples, team exercises and our industry knowledge and experience.

Gain practical insights into safe design, classifications and hazard protection in our basic course, or learn more about electrical hazardous, EMC techniques, methods for PEMS and more in our advanced course.

 

IEC 60601 Trainer

Gerrit Steinöcker

Functional Safety Consultant

IEC 60601 – Current dates

CourseIEC 60601 Introductory
Date12. Jul. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Advanced
Date13. Jul. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Introductory
Date13. Sep. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Advanced
Date14. Sep. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Introductory
Date11. Oct. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Advanced
Date12. Oct. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Introductory
Date15. Nov. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Advanced
Date16. Nov. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Introductory
Date06. Dec. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 60601 Advanced
Date07. Dec. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File

Testimonials

With Lorit Consultancy we have found an extremely reliable partner who sees the big picture. Through their Functional Safety Engineering (ISO 26262) competence, we enjoy support at the highest level within our automotive product development. Remarkable is the smooth integration into our internal development team and the always professional & uncomplicated communication. We look forward to many more joint projects!

Harald Sporer – Senior Project Manager, Automotive Sense & Control, Infineon

“It was really a very helpful and excellent training!”

Marco Augustin – Quality and Software Manager, Occyo

 

”Lorit Consultancy´s support was instrumental in helping us achieve compliance in IEC-62304/ 82304 and ISO 14971 for our software-as-a-medical-device product.”
Ju Zhang – Founder, CEO Formus Labs

 

“Plexus has used the services of Lorit Consultancy in relation to a new healthcare project where insights into ISO 14971 and IEC 60601-1 international standards was needed.  We have been very impressed with the quality of knowledge within Lorit and the quality of documentation and deliverable, and we look forward to continuing to partner with Lorit in the future.”
John Simpson – Senior Manager, Engineering  Plexus

“Lorit Consultancy gave us excellent support in defining the requirements and implementing the BS EN 62304 document structure for our first product.”
Selly Saini – CEO  Inside Biometrics

“Lorit Consultancy provided a professional and efficient service in defining regulatory requirements for both new developments and legacy products.”
Alastair Mutch – VP Research and Development, Diagnostics Cardiology Spacelabs Healthcare

“Lorit Consultancy gave us great support when guiding us through the process of hardware metric generation as defined in ISO 26262.  Providing both the FMEDAs and training on the use of them.”
Geoff Owen Protean

“Very well executed, very helpful. Thank you for your time and expertise.”
Senior Electronics Engineer

 

“Essential for my job. Reduced my fear of 60601.”
Senior Mechanical Engineer

“It’s great to have the opportunity to receive this training from somebody who is obviously an expert in the topic and understands the practical implementation.”
Senior Design Assurance Engineer