Resources
Expand your learning with our comprehensive library of free downloadable guides covering Risk Management, PFAS explainers, MDR & IVDR checklists and much more.
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.
MDR Labelling Requirement Identifier
The increase in requirements and any associated labelling changes brought about by the EU MDR will have varying levels of cost and resourcing implications for you as a manufacturer.
This report features tables which can be used as a high level guide to indicate what requirements of GSPR 23 may be applicable to your device.
EU MDR GSPR Checklist
Under the Medical Device Regulation, the General Safety and Performance Requirements (GSPRs) of Annex I are more demanding than their Medical Device Directive counterparts, the Essential Requirements.
Where the Directive included 13 Essential Requirements, the Regulation has 23 requirements that must be considered.
EU IVDR Readiness Checklist
This checklist has been created by our industry-leading experts to provide you with an insight into your level of preparedness and understanding of the EU IVDR.
EU IVDR GSPR Checklist
Under the IVD Regulation, the General Safety and Performance Requirements (GSPRs) of Annex I are more demanding that their IVD Directive counterparts, the Essential Requirements.
Where the IVD Directive included 13 Essential Requirements, the IVD Regulation has 20 requirements that must be considered.
IVDR Acronyms Guide
To help you navigate the daunting process of implementing the requirements of the IVD Regulation, we have compiled a glossary of the most commonly used acronyms, terms and definitions.