IEC 62304

Training Dates

IEC 62304 Consultancy & Training

The team at Lorit Consultancy has many years of experience in the field of software development in the medical technology industry and is therefore a competent partner for the application of IEC 62304 Medical device software – software life cycle processes.

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

 

About IEC 62304

In healthcare, the use of software is becoming increasingly important and can contribute to more efficient and safe patient care.

The international standard IEC 62304 specifies requirements for software lifecycle processes – both for embedded and standalone software, such as for medical apps. The requirements relate to software development, maintenance, risk management, configuration management and problem-solving processes.

IEC 62304 relation to other standards

Risk management and control are integral parts of the IEC 62304 standard, which also refers to ISO 14971: Risk management for medical devices. Furthermore, usability and the respective standards IEC 62366: Usability engineering for medical devices and IEC 60601: Safety requirements for medical electrical (ME) equipment and in medical systems are taken into account in the development and use of software.

When developing standalone software – software that is to be brought to market without dedicated hardware – the standard IEC 82304-1: Health software – Part 1: General requirements for product safety also applies.

 

Our services

Consultancy & Support:

  • Software risk analyses, metrics and cybersecurity
  • Software reviews at system-, item- and unit level
  • Writing work products

Training:

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

In our IEC 62304 Introductory course you learn the basics and in the IEC 62304 Advanced course the implementation and application of the standard with work examples, team exercises and our industry knowledge and experience.

You will be guided through the entire V-model from the requirements process to verification, and in our advanced course you will learn various methods and strategies for the implementation of your projects.

IEC 62304 Trainer

Alastair Walker

Owner/Consultant

IEC 62304 – Current dates

CourseIEC 62304 Introductory
Date13. Dec. / 1 Day
TrainerAlastair Walker
Costs€700 / £650
File
CourseIEC 62304 Advanced
Date14. 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