Date/TimeJune 30, 2022
The ISO 14155 Standard (Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice) has undergone significant changes in its latest edition released in 2020. This third edition of the ISO 14155 Standard introduces clarifications to facilitate compliance with other international clinical trial standards, such as the International Council for Harmonisation Good Clinical Practice (ICH-GCP).
The main goal of the most recent ISO 14155 changes is to ensure that the standard keeps its global acceptance by regulatory authorities. Conducting clinical studies according to GCP is important, not only to collect high-quality data under ethical conditions, but also to meet regulatory compliance within the EU and the United States.
Also important to note is the acceptance by the U.S. Food and Drug Administration (FDA) of the ISO14155 standard for medical device trials and the acceptance of clinical data collected outside the U.S. under the condition that ISO14155-GCP has been followed.
There are several key changes that Sponsors must consider throughout clinical trial strategy planning, including:
- Recognition of ISO 14155-2020
- Summary of GCP principles (Clause 4)
- Registration of the clinical investigation in a publicly accessible database (Clause 5.4)
- Risk-based monitoring and considerations when writing the monitoring plan (Clause 6.7)
- Clinical quality management (Clause 9.1)
- Statistical considerations (Annex A)
- Guidance for ethics committees (Annex G)
- Risk management throughout the entire process of a clinical investigation (Annex H)
- ISO 14155 GCP requirements for different clinical development stages (Annex I)
- Guidance on clinical investigation audits (Annex J)
Join NAMSA for this webinar as we walk through an overview and understanding of the ISO 14155 standard changes, discuss how this compares to the previous 2011 version and explore why adoption, planning and implementation are key to commercial success.
Upon conclusion of the program, participants will:
- Understand the key changes of ISO 14155:2020
- Know how these changes impact clinical strategy and investigations
- Be better equipped to implement clinical strategies focused on global compliance
- Identify actions needed to meet these updated requirements
Dr. Maria NyåkernExecutive Director, CRO Services
Dr. Maria Nyåkern is clinical research scientist and medical device executive with a broad understanding of the clinical development and commercialization process of medical device technology. Dr. Nyåkern has 15 years’ experience working for medical device start-ups, as well as for global manufacturers like Abbott, Medtronic and Cordis. She has an extensive experience in planning and executing clinical investigations required for regulatory submissions, as well as Post-Market Clinical Follow-Up (PMCF) studies. She also has a solid track record of successfully collaborating with relevant stakeholders, authorities, clinicians and medical device executives, worldwide. In 2017, Dr. Nyåkern established ÅKRN Scientific Consulting, a European CRO offering clinical and regulatory services to the medical device and diagnostic industries. In 2022, ÅKRN and its 40+ employees was acquired by NAMSA.
Dr. Nyåkern’s core competencies include CRO business operations, clinical strategic/optimization planning, clinical evaluation and medical technology business development, as well as Subject Matter Expertise (SME) on EU MDR 2017/745, ISO 14155:2020 and CE-mark strategy. She is a member of the ISO technical committee for biological and clinical evaluation of medical devices (SIS/TK 340 and ISO/TC 194) responsible for developing the ISO 14155 standard regulation clinical investigations of medical devices in human subjects. She is a renowned speaker and trainer on the topic of clinical evaluation and clinical investigation of medical devices.
Dr. Maria Nyåkern has a strong academic background and international scientific training in Sweden, France, Italy and the United States (U.S.). She is the author of several peer-reviewed papers in the cardiovascular area and she is fluent in English, Spanish, Italian, French and Swedish.