Ask the right questions: Establish your strategic plan by aligning your evidence development plan with your clinical benefits intended use goals and stakeholder.
Empirical Clinical Solutions provides expert advice and flexible support for medical device technologies and pharmaceutical companies that help navigate regulatory frameworks, bring new products to market and deliver better patient outcomes. As a specialist advisor and trainer on the EU MDR 2017/745, ISO standard and ICH-GCP/ISO14155, we support clients to deliver sustainable value in healthcare throughout the full product lifecycle.
This is an online, in person training course scheduled for 18th of May 2023, (09.00 – 16.00) consisting of a 1 day course and a final assessment quiz.
The intent of the ISO14155:2020 standard training program is to provide crucial guidance and support to any party involved in the conduct of Clinical Investigations with human participants – Sponsors (including monitors) and investigators, but also includes ethic committees, regulatory authorities and notified bodies assessing the conformity assessment of medical devices.
The new version of the ISO standard aligns with the European Medical Device Regulation (EU MDR 2017.745), the ICH E6 (R2) guidelines n Good Clinical Practice and FDA guidance documents with a focus on medical devices. The updates ensures the standard is relevant and maintain acceptance by the global medical device industry. The focus of the updates is on the increasing demand to demonstrate safety and data reliability.
Fee: €600
For medical device companies
We support you to achieve CE Mark/FDA approval and market access for new medical technologies.
For pharmaceutical companies
Program management, site monitoring and audit preparation that helps achieve ethical, scientific and regulatory requirements. Read more.
Why Empirical Clinical Solutions?
- Ireland’s exclusive clinical strategy consultancy
- Works to best practice in all phases of clinical studies
- Full product lifecycle approach
- Verified expertise in EU MDR 2017/745 and FDA requirements
- Trainer for ICH-GCP/ISO14155;2020
- Committed to patient advocacy
- Deep understanding of Irish research infrastructure
- Extensive European network of expertise
Ask the right questions:
Establish your strategic plan by aligning your evidence development plan with your clinical benefits intended use goals and stakeholder values.
Are you ready for the MDR?
The new European Union Medical Device Regulation will come into effect in 2021 and hold medical device manufacturers to a new compliance standard. Do you know how to get your product CE marked under the new regulation?