ISO 13485

Training Dates

ISO 13485 Consultancy & Training

The team at Lorit Consultancy has many years of experience with quality management systems for medical devices and is therefore your competent partner for the application of ISO 13485 – Quality management systems – Requirements for regulatory purposes.

About ISO 13485

ISO 13485 regulates the basic requirements for a quality management system for manufacturers of medical devices and other medical technology stakeholders.

The requirements include management responsibility, resource management, product realization and service provision, and measurement, analysis, and improvement.

ISO 13485 relation to other standards

ISO 13485 extends the requirements of ISO 9001 for a quality management system to include the specific requirements for medical devices.

The requirements of ISO 13485 partially overlap with the requirements of IEC 62304 Medical device software – software life cycle processes and the IEC 60601 family of standards. ISO 13485 supports the requirements of IEC 62304 and the IEC 60601 family of standards, for example in the product manufacturing process, in the change management process and the CAPA process. ISO TR 20416 is used to support the required post-market-surveillance process.

The required internal audits are successfully implemented by complying with the specifications in ISO 19011.

Our services

Consultancy & Support:

  • Quality management manual, quality policy and quality objectives
  • Responsibility of the management
  • Resource Management
  • Product realization and service provision
  • Measurement, analysis and improvement
  • Implementation and documentation of the processes required for the quality management system
  • Medical device file
  • Control of documents and records
  • Qualification of software tools
  • Validation of software tools
  • Applicable regulatory requirements
  • Post-market- surveillance
  • Implementation of external audits and support for internal audits

Trainings:

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

In our ISO 13485 course, we introduce you to the basics of the standard using work examples, team exercises and our industry knowledge and experience.

You will get an overview of the responsibility of management and the resource management. Processes for product realization and service provision are also considered. The course introduces you to processes for measurement, analysis and improvement.

You will learn the differences to ISO 9001 and how to meet the requirements of the Medical Devices Regulation (MDR) by implementing ISO 13485. The course also provides information on quality management systems in other countries, such as the USA  (21 CFR 820), and compares quality management systems in other safety-related industries, such as the automotive industry.

The course covers validation of software tools, planning and conducting internal audits according to ISO 19011, and planning and conducting post-market-surveillance.

The course also introduces the Medical Device Single Audit Program (MDSAP). With the MDSAP, compliance with the regulatory requirements of the USA, Brazil, Japan, Australia and Canada can be proven with a certification process.

ISO 13485 Trainer

Verena Wieser, Medical device consultant at Lorit

Verena Wieser

Medical Device Consultant

ISO 13485 – Current dates

CourseISO 13485
Date24. Jun. / 1 day
TrainerVerena Wieser
Costs€700 / £650
File
CourseISO 13485
Date24. Jul. / 1 day
TrainerVerena Wieser
Costs€700 / £650
File
CourseISO 13485
Date27. Aug. / 1 day
TrainerVerena Wieser
Costs€700 / £650
File
CourseISO 13485
Date23. Sep. / 1 day
TrainerVerena Wieser
Costs€700 / £650
File

Testimonials

Companies around the world rely on our extensive knowledge in safety-relevant industries when developing their products.

In summary; very useful, the recommendations/observations are recognisable and the report will help steer future 62304 compliance efforts.
In addition, the report also satisfied our external stakeholders.

Phil Cooley – Quality Manager, Bond Digital Health Ltd

 

Thank you, for a terrific course!
The trainer was extremely knowledgeable about the material, and made the content very easily digestible, even the more challenging bits.  I am very satisfied.

Rhyse Jaeschke – Manager, System Verification & Validation Ultrasound R&D, Philips Healthtech

Philips

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

“Excellent course and very pragmatic approach on implementing compliance.”
Senior Software Engineer

“The instructor was extremely engaging and clearly had excellent knowledge of the material.”
Innovation Agent