5:00 PM – 6:30 PM, Central European Time (CET)
11:00 AM – 12:30 AM, Eastern Time (ET)Time
Overview
The Medical Device Single Audit Program (MDSAP) is one of the toughest regulatory hurdles in the medical device industry. Navigating it successfully means unlocking access to five of the largest global markets, all through a single audit. This is your chance to streamline compliance and accelerate your product’s international reach.
Are you ready to transform your approach to MDSAP? Join our exclusive, expert-led webinar designed specifically for medical device professionals striving for audit success. Discover the operational foundations that will set your company apart and ensure a smooth, efficient audit process.
In this comprehensive session, you’ll uncover:
– The essential operational ingredients critical for MDSAP success
– How to design a controlled, right-first-time roadmap that minimizes risk
– Common pitfalls and hurdles—so you can plan ahead and avoid costly setbacks
– Proven top tips to achieve audit readiness and boost your confidence
– Equip your team with the knowledge and strategies not just to pass, but to excel in your MDSAP audit.
Don’t miss this opportunity to gain expert insights that can fast-track your market entry and regulatory compliance.
Reserve your spot now and take the first step towards mastering MDSAP audit readiness!
Speakers
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Sumatha KondaboluSenior Quality Business Partner, QualioSumatha has 19 years of QA/RA experience across the medical device and pharmaceutical sectors.
She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU’s MDR, IVDD and IVDR.
She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949.
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Heinz StenebergPresident & CEO, MDSS USAHeinz Steneberg joined MDSS USA in May 2025 as President and CEO. MDSS offers in-country representation and consulting services for companies marketing medical devices and in vitro diagnostics in the US, EU, UK, Switzerland, and Australia.
Before joining MDSS, Heinz spent over 25 years in regulatory affairs and quality management, holding leadership positions at Quest Diagnostics, Roche Molecular Diagnostics, Abbott Diabetes Care, Carl Zeiss Meditec, and Medtronic Vascular.
Heinz established regulatory strategies and led teams through successful regulatory submissions, including IDEs, PMAs, 510(k)s, BLAs, and EU MDR and IVDR dossiers. He led quality management teams and served as Management Representative and Person Responsible for Regulatory Compliance (PRRC).
Earlier in his career, Heinz was the Division Manager of TUV Rheinland of North America’s Medical Division, supporting CE Marking projects for clients in the medical device industry.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
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Who Should Attend
- Medical device QA/RA
- Compliance professionals
- Skill Level Novice
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Topics
- A broad understanding of the requirements of the MDSAP program and how to comply.
- Operational ingredients/processes/documentation required to get started.
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Special event information
Participants will recieve a certificate of attendance.
Time
5:00 PM – 6:30 PM, Central European Time (CET)
11:00 AM – 12:30 AM, Eastern Time (ET)
Speakers
-
Sumatha KondaboluSenior Quality Business Partner, Qualio
Sumatha has 19 years of QA/RA experience across the medical device and pharmaceutical sectors.
She has built quality management systems for compliance with the FDA QSR, Canada’s Medical Devices Regulations, NIOSH, MDSAP, COFEPRIS, and the EU’s MDR, IVDD and IVDR.
She holds a Master’s in Chemistry and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, ISO 9001 and IATF 16949.
-
Heinz StenebergPresident & CEO, MDSS USA
Heinz Steneberg joined MDSS USA in May 2025 as President and CEO. MDSS offers in-country representation and consulting services for companies marketing medical devices and in vitro diagnostics in the US, EU, UK, Switzerland, and Australia.
Before joining MDSS, Heinz spent over 25 years in regulatory affairs and quality management, holding leadership positions at Quest Diagnostics, Roche Molecular Diagnostics, Abbott Diabetes Care, Carl Zeiss Meditec, and Medtronic Vascular.
Heinz established regulatory strategies and led teams through successful regulatory submissions, including IDEs, PMAs, 510(k)s, BLAs, and EU MDR and IVDR dossiers. He led quality management teams and served as Management Representative and Person Responsible for Regulatory Compliance (PRRC).
Earlier in his career, Heinz was the Division Manager of TUV Rheinland of North America’s Medical Division, supporting CE Marking projects for clients in the medical device industry.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
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