Medical Devices Regulatory Training
ISO 13485

ISO 13485 shapes quality management systems for medical device manufacturers the world over. The international standard shows customers and competitors that you take quality seriously. Sign up for our Introduction to ISO 13485 Medical Devices Training Course and don’t get left behind.

ISO 13485 applies to design, development, production, installation and servicing of medical devices. And compliance is a measure of your ability to meet customer and legal requirements.

"Our international reach is unrivalled with operations in 147 countries"

On this one day course we will explain how ISO 13485 is implemented and draw links with other quality standards. You will review and compare ISO 13485 requirements with ISO 19001:2008 and the Food and Drug Administration (FDA) Quality System Regulation and you will begin to understand the relationship between ISO 13485 and ISO 14971:2007 (Application of Risk Management to Medical Devices).

Attend BSI’s “Introduction to CE Marking” one day course and start making informed decisions with regard to meeting the requirements of the EU Medical Devices Directives. 

On completion of training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly.

Understanding the In Vitro Diagnostics Directive (IVDD) is vital to marketing medical devices in the EU. Our Introduction to CE Marking for the In Vitro Diagnostics Directive outlines all you need to know about making your products IVDD compliant to gain European market access.

IVDD is one of three directives that monitor product quality and safety within the CE framework. And you will need IVDD compliance if your device is designed to diagnose medical conditions without patient contact.

“We chose BSI for its international reputation for excellence. It is a trusted organisation with unrivalled experience.”

Our one day course will explain the entire process. Working with our qualified practitioners you will understand what’s required by the IVDD and CE Marking. And you can go on to develop IVD quality products, meet safety standards, gain EU market access, satisfy customers and maintain compliance throughout the product lifecycle.

Manage risk effectively and see business success with our ISO 14971 Medical Risk Management Training Course – an essential and international accreditation for all medical device manufacturers.

The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance.

“The delegates were given freedom to discuss their own experiences and the tutor related these experiences to the course.”

Our course is delivered by professionals with unrivalled practical experience and designed to help you get to grips with ISO 14971. In just one day you will understand how the standard can improve risk management within your business, as well as drawing links with quality management standard ISO 13485:2003 – focussing on 2007 changes. You will take away the tools to confidently manage risk to an international standard.

Reduce risk, avoid mistakes and speed up compliance with EU Medical Device Directive (MDD) regulations by completing Device-Drug Combinations: Borderline Issues and Consultation Process Guidance. This one day training course is designed to help device-drug manufacturers prove products are safe for market.

“The tutor undertook the course with enthusiasm, and allowed each group member to provide input into the day.”

If you work with ancillary medical substances or derivatives of human blood or plasma, we can help you remove all uncertainty from the consultation process. We will outline ISO 13485:2003 and EU MDD requirements, allowing you to establish realistic timescales and avoid common errors that can cause delays and working with our experts, you can be confident of ISO 13485:2003 and EU compliance.

The course is recognised by the Medicines and Healthcare products Regulatory Agency.

Make sure your medical devices meet customer, quality and regulatory standards with our Process Validation for Medical Devices Training Course. This course is a must for all involved in manufacturing, regulation and development – and will help you quickly meet ISO 13485, EU and Food and Drug Administration (FDA) requirements.

Validating medical devices need not be complex when you understand all that’s involved. Working with us you can get to grips with regulatory and safety standards and quality assurance. You will become confident developing devices in line with the FDA’s Quality System Regulation and ISO 13485 – reducing development time and gaining earlier access to market.

"The course was delivered at the right pace."

Our qualified tutors give you the process validation tools and techniques that can be put into practice as soon as you complete the course.

Capturing customer feedback and managing risk is crucial to the success and compliance of all medical devices. Achieve both with our Medical Device Post Market Surveillance and Vigilance Training Course – helping you gather data to secure continued compliance with the Food and Drug Administration (FDA) and Medical Device Directives (MDD).

Our one day course will give you the tools to carry out successful post market surveillance. Explore ways to capture feedback, record market trends and understand how regularly monitoring data can improve quality and safety controls. You will also learn to handle complaints, clinical follow up, quality and risk management, and MDD and FDA compliance.

“The course was delivered in a clear manner and easily understood.”

Identifying and using the right information will keep you one step ahead. Complete the course and you can confidently carry out effective post market surveillance and increase market access.

BSI’s Writing Technical Files for Compliant Devices one day course is designed to support manufactures by confirming current regulatory requirements of technical documentation.  The aim of the course is to speed the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union.

On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.  

Attend BSI’s ‘introduction to the SFDA new mandatory MDIR and the online application process’ one day course and start making informed decisions with regard to meeting the requirements of the SFDA.

On completion of this training course, participants will gain an:

• appreciation of these mandatory regulations
• ability to identify potential commercial impact to their business
• ability to interpret the regulations, to advise the organization on regulatory compliance and fee structure.

Clear guidance will be provided in relation to the on-line application process in order to establish or maintain market authorisation.

Become a CE Marking leader with our Medical Devices CE Marking Training Course and ensure quicker access to market for your products. Work with qualified trainers to understand the entire CE Marking process in line with the European Medical Devices Directive (MDD). 

MDD applies to all general medical devices and compliance is essential in gaining access to the EU market. Gain in-depth knowledge of the MDD structure and identify steps to remove the uncertainty of CE Marking and EU regulatory processes. Become confident in assessing medical devices, quickly identifying risks and reporting product changes – and ensure your medical devices quickly meet safety and quality standards.

“Professionally presented and run – an excellent course.”

You will walk away with leadership skills and play a key role in successfully placing medical devices on the EU market.

Put quality first with our Implementing ISO 13485:2003 Training Course – make sure your medical devices are internationally recognised and meet legal and customer requirements.

“While quality has always been our number one priority, we now have a more systematic approach to the way it is managed.”

This course shows you how to put in place a quality management system in line with ISO 13485:2003, paving the way to accreditation. ISO 13485 is a clear mark of your commitment to quality and applies to every aspect of medical devices from design to development, production and servicing. You will learn step by step how to plan, develop and implement a quality management system. Working with our experts, you will take away the skills to achieve and maintain best quality management practice, gain customer confidence and quicker access to market.

BSI’s “Application of the In Vitro Diagnostics Directive” three day course has been designed to enable participants to explore the IVD Directive, gain a greater understanding of the requirements and thus enable IVD devices to be placed on the European market.  

Participants will be able to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle.

Managers and quality/regulatory professionals responsible for all aspects of IVD CE marking as well as internal and external auditors, will benefit from attending this course.

Complete our Internal Auditor ISO 13485 Training Course, guarantee the highest quality standards and remove barriers to market for medical devices. Gain auditing skills to confidently guide your organisation towards ISO 13485 accreditation – an essential standard for all medical device manufacturers.

ISO 13485 outlines quality management system requirements for design, development, production and servicing of medical devices and related services.

“We are continually securing new business because of our certification.”

Get to grips with the entire internal auditing process, learn to plan audits, report on results and lead on follow up action.

This two-day course is recognised by the Medicines and Healthcare Products Regulatory Agency.

Take the lead in quality management for medical devices with our Lead Auditor ISO 13485 Training Course. Guide your organisation towards quality management excellence and ISO 13485 accreditation – and remove barriers to market for medical devices, gaining competitive advantage.

Work with qualified tutors over five days to consolidate your knowledge of ISO 13485 and ISO 19011:2002. Understand the entire audit process at lead level, from planning to managing and reporting on results and learn through tutorials and practical exercises to become a recognised auditing professional for ISO 13485 and ISO 19011.

"We are proud to have the standard. It gives us enormous credibility with our potential customer base and with that credibility we give them confidence."

You will take away the leadership and specialist auditing skills to help others understand and implement effective quality management systems in medical device manufacturing.

Ensure that your audit programme is performed to the highest standard by having your team qualified as BSI Registered Auditors. Your auditors will continue to improve their skills through the qualification, leading to improvements to your business and increased value and relevance of the audit results. 

“Qualifying as a BSI Registered Auditor was highly enjoyable and provided a valuable evaluation of my auditing skills."
Nir Barak, Registered Auditor  

Benefits of the qualification

• Career development
• Excellent training, progression and a professional qualification
• Ensures that audits deliver benefits specific to your business
• Contribute to the effectiveness of your corporate governance
• Stay up to date with the latest developments, ensuring ongoing excellence in performance