EMC Resources

BSI training courses, business improvement courses and qualifications to help you, and your organization, progress towards a more sustainable and resilient future.

Forward thinking individuals and organizations use BSI’s training courses and qualifications to embed new skills and expertise and to progress towards a more resilient and sustainable future. Our learning allows organizations to grow opportunities, overcome challenges and deal with uncertainty to succeed in their markets.

Delivered in person, online, on-demand or a blended approach around the world, for maximum flexibility.

Requirements of the Medical Device Regulation for CE Marking

This one-day medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers. 

This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors…….
Duration: 1 Day, Venue: Live On-line & Live On-Site
LINK for FULL DETAILS and REGISTRATION

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Introduction to Medical Device Software

Gain an understanding of the medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements…..
Duration: 1 Day, Venue: Live On-line
LINK for FULL DETAILS and REGISTRATION

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Technical Documentation for the Medical Device Regulation

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:

• Create robust technical documentation to demonstrate compliance to the MDR
• Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process…..
  Duration: 1 Day, Venue: Live On-line
  LINK for FULL DETAILS and REGISTRATION

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Implementation of Medical Device Regulation for CE Marking

This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR). The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers. 

You will learn all the requirements needed for conformity assessment, how to fulfil technical documents and how to plan post-market activities required by the MDR. By the end of the course you will be able to put all this knowledge into working practice in your organization…..
Duration: 3 Days, Venue: Live On-Line & Live On-Site
LINK for FULL DETAILS and REGISTRATION

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Additional Courses on this Topic

The hidden stings of the Medical Device Regulation (MDR) – Annex VII

Duration: 1 Hour, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION

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Requirements of the Medical Device Regulation (MDR)

Duration: 4 Hours, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION

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Requirements of the In Vitro Diagnostic Regulation

Duration: 4.5 Hours, Venue: On-demand elearning
LINK for FULL DETAILS and REGISTRATION

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Manufacturing Process Validation for Medical Devices

Duration: 1 Day, Venue: Live On-line
LINK for FULL DETAILS and REGISTRATION

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ISO 14971:2019 Risk Management for Medical Devices

Duration: 1 Day, Venue: Live On-line
LINK for FULL DETAILS and REGISTRATION

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Clinical Evaluation for Medical Devices

Duration: 1 Day, Venue: Live On-line
LINK for FULL DETAILS and REGISTRATION

Process Improvement: Auditor – Core Tools (Aerospace) 

This two-day training course is specially designed to provide in-depth knowledge and develop necessary skills on how to effectively audit aviation, space and defence organizations and their adoption of core tools. The course will encourage auditors to move beyond basic conformity, and effectiveness auditing, and consider the appropriateness and suitability of organization practices/process controls. The core tools, when applied, will be evaluated in light of the strategic purpose, direction and context of an organization.

The course is built around a comprehensive Case Study and tailored workshops to assist in the development of the necessary skills……
Duration: 2 Days, Venue: In-house/Private Only
.LINK for FULL DETAILS

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Aerospace Measurement Systems Analysis (MSA)

Learn about the methods used to assess the quality of a measurement system, and to understand the sources of variation present and the impact on the measurement result.

This one-day course provides an overview of the generic aerospace methodology for measurement systems analysis, as defined in AS13003. It also details the typical methods used to evaluate both variable and attribute measurement systems….
Duration: 1 Day, Venue: In-house/Private Only
LINK for FULL DETAILS

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Aerospace Process Failure Mode and Effects Analysis

(PFMEA) with Design FMEA Consideration Training Course

This one-day course provides an overview of the methodology used to develop and implement process and design FMEA; detailing the critical steps to identify and mitigate process and product risks. Whilst the course is based around AS13004:2017 and gives emphasis to Process FMEA, consideration is given into how the same principles can be applied in the context of Design FMEA….
Duration: 1 Day, Venue: In-house/Private Only
.LINK for FULL DETAILS

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Aerospace Statistical Process Control (SPC) 

Learn how Statistical Process Control can be used to evaluate process capability and process performance.

Statistical Process Control (SPC) is commonly used by aerospace manufacturers as part of quality control programs. Application of the SPC methodology can help you to quickly identify when processes are producing results outside their normal variances. This in turn enables organizations to continuously improve product quality, limiting scrap and waste, and reduce costs.

This one-day course provides an overview of the aerospace methodology for the use of statistical techniques detailing the critical steps in the best use of statistical techniques to evaluate both attribute and variable data……
Duration: 1 Day, Venue: In-house/Private Only
LINK for FULL DETAILS

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Aerospace First Article Inspection (FAI) 

AS9102 is a structured framework to plan and complete actions of the product realization cycle which are necessary to ensure quality product(s) are delivered on time, while satisfying cost performance targets.

This one-day course provides an overview of the tools, procedures and reporting requirements specified in AS9102; detailing the phases FAI and the desired outcomes….
Duration: 1 Day, Venue: In-house/Private Only
.LINK for FULL DETAILS

IATF 16949 Requirements

In today’s fast paced environment, customers are more demanding and competition more intense. Delivering quality products and services is more crucial than ever for survival and long-term success. Having an internationally recognized Automotive Quality Management System (Automotive QMS) allows you to enhance organizational performance, increase customer satisfaction and gain a competitive edge.

This course will help you identify key requirements, and the structure of an effective Automotive QMS and what this means for you. Gain a thorough understanding of the history and development of IATF 16949:2016, key terms, definitions and the integration and the alignment to the ISO standardized high level structure. You’ll learn to interpret the key concepts and principles of the standard…..
Duration: 2 Days, Venue: Live On-line
LINK for FULL DETAILS and REGISTRATION

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IATF 16949:2016 Implementation

Develop the knowledge and skill required to implement an IATF 16949:2016 Automotive Quality Management System (AuQMS).

Good businesses understand quality; great businesses implement it. An ineffective AuQMS can cost you time, money and customers. That’s why it’s important to get it right from the start. Implementing a framework based on IATF 16949:2016 helps your business consistently deliver and drive continual improvement in your products and services.

Gain the required skills to conduct a base-line review of your organization’s current position and implement the key principles of IATF 16949:2016. Using a step-by-step approach, you’ll learn how to develop an implementation plan, create necessary documentation, monitor your AuQMS and achieve continual quality improvement…….
Duration: 3 Days, Venue: In-house/Private Only
LINK for FULL DETAILS

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IATF 16949:2016 Understanding Core Tools for Internal Auditors

An ineffective audit can mean severe consequences; resulting possibly in process failure, customer dissatisfaction and regulatory noncompliance. The automotive sector requires internal auditors to demonstrate minimum competencies. This includes understanding of applicable core tool requirements, related to the scope of the audit.

This course develops the necessary knowledge and skills to ensure that you can assess and report on the effective implementation of core tools within your organization. You’ll learn how to audit the core tools effectively, and give meaningful feedback through audit reporting and audit follow-up activities…..
Duration: 1 Day, Venue: In-house/Private Only
.LINK for FULL DETAILS

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AIAG and VDA DFMEA

This two-day course provides you with a hands-on approach using a Case Study to develop a PFMEA using the new methodology in line with the methods specified in the AIAG VDA Failure Mode and Effects Analysis FMEA Handbook Edition 1. The course takes delegates through the new 7 step approach using the Case Study which allows delegates to practice each of the 7 steps……
Duration: 2 Days, Venue: In-house/Private Only
LINK for FULL DETAILS

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AIAG and VDA FMEA – What’s Changed.

This one-day course provides an overview of the new methodology used to develop both design and process Failure Mode and Effects Analysis (FMEA) in line with the methods specified in the AIAG VDA Failure Mode and Effects Analysis FMEA Handbook Edition 1, taking you through the new 7 step approach using practical examples……
Duration: 1 Day, Venue: In-house/Private Only
LINK for FULL DETAILS