Knowledge Hub
Welcome to the Knowledge Hub – your access portal to a range of educational resources to improve your understanding of both Trinzo and the life sciences industry.
Learn how we could add value to your business by delving into our case studies – varied examples of challenges that we helped our clients resolve. Access our training guides such as EU MDR and IVDR, to improve your knowledge and comprehension of training course material.
Case Studies
Real-world examples showcasing our consulting and training team in action.
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Bespoke eLearning Solutions
Our global client was in the middle of a remediation process. They were struggling with:, Inconsistent global procedures, Poor Validation Knowledge & Culture globally Siloed sites and business lines, Over 47 sites with multiple languages
Voice of the Business for Information Purposes
To facilitate communication between teams, and identify areas where the client could reduce the complexity, time and cost of doing business. This client was not optimising technology to reach its strategic goals. Many of the IS activities were reactive rather than proactive – and they knew they needed help.
Leveraging Digital Capabilities
Trinzo partnered with a large multinational organisation to help resolve a number of key issues. The client struggled with a bloated headcount, non-standard work across sites, and a lack of global oversight. These issues had been growing incrementally over the years, due to fast growth and multiple acquisitions.
Guides
Bolster your knowledge and improve compliance with our detailed guides and checklist.*
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The Ultimate Clinical Data Evaluation Checklist
The definitive guide to identifying potential gaps in your clinical evaluation.
The EU In Vitro Diagnostic Regulation Handbook
A comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
The EU Medical Device Regulation Guidebook
Providng you with an overview of the requirements of MDR so you can demonstrate compliance confidently.
Resources
An extensive collection of free downloadable guides covering Risk Management, PFAS explainers, MDR & IVDR checklists and much more
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Risk Management Plan Template
Navigating risks can be challenging and our industry-leading experts are here to help. Our brand-new Risk Management Plan template contains all the basic elements needed to comply with the risk management report requirements of ISO 14971:2019.
This downloadable template comes with instructions and explanations to get you started.
PFAS Acronym Guide
Achieve clarity on acronyms used in PFAS research, regulation, and remediation efforts.
Whether you’re grappling with deciphering regulatory frameworks, interpreting scientific studies, or need to communicate effectively within interdisciplinary teams, this guide demystifies PFAS-related terminology so that you can get ready for any incoming restrictions.
Periodic Safety Update Report Template
As per Article 86 of the MDR, the Periodic Safety Update Report (PSUR) is a new requirement under the regulation, and is applicable to class IIa, IIb and class III devices.
The PSUR forms part of the technical documentation as outlined in Annexes II and III of the MDR.
An up-to-date blog to keep you informed of company and industry news. Our podcast library also ensures your team has a finger on the pulse of the latest developments in this space.
Podcasts
Trinzo’s experts discuss key industry topics, ensuring your team keeps a finger on the pulse.
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