Medical Devices Training Courses

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

Cosmetovigilance

Updated for 2023

Live online
Focused

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

Cyber Security for Medical Devices

Live online
Focused

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

Delivery of Biologics to the Nasal Cavity

New for 2023

Live online
Focused

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

Human Factors - The Increasing Importance of Instructions for Use

Free

Live online
High impact

This free webinar will focus on the often overlooked but increasingly important area of Instructions for Use for medical products. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be. This is an excellent opportunity to learn more about this important element of your regulatory submission.

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

Masterclass: Artificial Intelligence-enabled Medical Devices

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Live online
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

Medical Device Single Audit Programme (MDSAP)

New for 2023

Live online
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

Quality Management Refresher

New for 2023

Live online
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

Sterilization of Medical Devices

New for 2023

Live online
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

The Medical Device Summer School - From Concept to CE Marking

Summer school

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.