Technical specialist
Dr Juliane Rossato
Biocompatibility, ISO 10993 and biological evaluation. HSC Academy instructor. Leads the 30-minute technical session and practical case.
Free live roundtable
ISO 14155:2026 What changes in practice?
A live expert discussion on the most significant changes in the 4th edition. A conversation among professionals working in clinical investigations every day, rather than a lecture.
Who is behind the roundtable?
- Exemplar Global RTPFor MDSAP
- BSI backgroundModeration with a regulated-market background
- HSC AcademyLead technical instructor
- ANVISA in practiceRDC 665/2022 and RDC 751/2022
What we will discuss
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Risk management in 3 categories
And its direct impact on your protocols.
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Estimands
Previously a pharmaceutical topic, now mandatory for devices.
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CECs and DMCs
The new approach to proportionate suspension.
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Consent and eligibility
Zero tolerance for deviations.
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Live practical case
A Class III device in a multicentre study.
30-minute technical session
Clause by clause, what changed from 2020 to 2026.
The roundtable opens with a technical presentation led by Dr Juliane Rossato: 30 minutes examining what changed from ISO 14155:2020 to the 2026 version and what this requires of those conducting medical device clinical investigations.
- 01 Timeline: from the 3rd edition to the 4th edition (2026).
- 02 The MDR harmonisation paradox.
- 03 Structural changes, clause by clause.
- 04 What to review in your QMS and protocols now.
Who is at the table?
Moderator
Nicolas Crispim
Founder of HSC Global Group, holder of the Exemplar Global RTP recognition for MDSAP. Former Commercial Manager at BSI. Leads the discussion and Q&A session.
Everything you need to know
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Date18 August 2026
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Time14:00Brasília time
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Duration2 hours
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FormatLive onlineRoundtable
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CertificateHSC GlobalFor live participants
Designed for those applying the standard
Regulatory and Quality
Medical device industry professionals.
CROs and clinical teams
CRO teams and clinical investigators.
Consultancy
Consultants who need to update QMSs and protocols.
ISO 14155 investigations
Those conducting or planning clinical investigations under the standard.
Quick questions
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Yes, 100% free.
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Yes, an HSC Global Certificate for live participants.
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Yes, there is a live Q&A session.
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The link will be sent by email and WhatsApp after registration.
Registration open
Secure your place
A free live discussion on what changes in ISO 14155:2026, with a 30-minute technical session by Dr Juliane Rossato. 18 August, at 14:00, with an HSC Global certificate for live participants.