Episodios

  • EU IVDR: Navigating New Deadlines and Stricter Rules

    EU IVDR: Navigating New Deadlines and Stricter Rules
    Aug 18 2025
    The European Union's In Vitro Diagnostic Regulation (IVDR) has replaced the IVDD, introducing a stricter, risk-based classification system and increasing Notified Body oversight for most devices. This episode breaks down the fundamental changes, the expanded scope that now includes software and genetic tests, and the critical extended transition deadlines established in July 2024, providing manufacturers with a clear roadmap for compliance. • What is the EU IVDR and how does it differ from the previous IVDD? • What are the new risk classifications (A, B, C, D) for IVDs? • How has the role of Notified Bodies changed under the new regulation? • What are the latest extended transition deadlines for high, moderate, and low-risk IVDs? • Are all IVD devices eligible for these extended deadlines? • What are the specific conditions for a legacy device to qualify for the transition period? • How does the IVDR affect medical device software and companion diagnostics? • What happens if a manufacturer’s IVDD certificate expired before the new extension? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 m
  • Navigating Canada's MedTech Market: A Guide to the CMDR

    Navigating Canada's MedTech Market: A Guide to the CMDR
    Aug 17 2025
    Canada's medical device market is a significant opportunity, but navigating its regulatory framework, the CMDR (SOR/98-282), is essential for market entry. This episode provides a comprehensive overview of the Canadian Medical Devices Regulations, from its risk-based classification system to licensing, quality management, and post-market surveillance obligations for manufacturers and importers. • What are the four risk classes for medical devices in Canada? • What is the difference between a Medical Device Licence (MDL) and a Medical Device Establishment Licence (MDEL)? • Which device classes require an MDL before being sold in Canada? • What is the mandatory Quality Management System standard for Class II, III, and IV devices? • How does the Medical Device Single Audit Program (MDSAP) fit into Canadian compliance? • What are the bilingual labelling requirements for devices sold to the public? • Who is responsible for mandatory incident reporting? • What are the key post-market surveillance activities required under the CMDR? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 m
  • EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance

    EU Clinical Trial Blueprint: Unpacking the MDCG 2024-3 Guidance
    Aug 16 2025
    This episode dissects the critical MDCG 2024-3 guidance issued in March 2024, which outlines the European Union's expectations for a Clinical Investigation Plan (CIP). We explore how this document harmonizes the EU MDR and ISO 14155:2020, establishing the best-practice blueprint for planning medical device studies. We break down the essential components your CIP must include, from the benefit-risk analysis and statistical design to data management and safety reporting, to ensure a successful regulatory submission. Key Questions: • What is the MDCG 2024-3 guidance, and why is it crucial for MedTech manufacturers? • How does this document unify the requirements of the EU MDR and ISO 14155:2020? • What are the core sections your Clinical Investigation Plan must now feature? • How should you structure the benefit-risk analysis to meet regulatory expectations? • What are the new guidelines for detailing statistical methods and data management? • How does the guidance address modifications, deviations, and adverse event reporting? • Is your current approach to clinical investigations compliant with these latest EU standards? • What information is required to demonstrate the scientific validity of your study design? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 m
  • Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers

    Navigating the UKCA Transition: Key Deadlines for Medical Device Manufacturers
    Aug 15 2025
    This episode breaks down the essential requirements of the UK MDR 2002, outlining the critical transition deadlines for moving from CE marking to the new UKCA mark. We cover the specific dates manufacturers need to know for 2028 and 2030, the mandatory role of the UK Responsible Person (UKRP), and the conformity assessment process with UK Approved Bodies. Learn the key steps to ensure your medical devices remain compliant for access to the Great Britain market. Key Questions: • What is the UKCA mark and how does it differ from the CE mark? • Can I still sell my CE-marked medical device in Great Britain? • What is the absolute final deadline for transitioning to the UKCA mark? • Do the transition timelines differ for devices under the EU MDR versus the older MDD? • What are the responsibilities of a UK Responsible Person (UKRP)? • Is it mandatory for a non-UK based manufacturer to appoint a UKRP? • How do the regulations for Northern Ireland differ from the rest of the UK? • What are the first steps my company should take to prepare for the UKCA transition? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 m
  • Unlocking U.S. Clinical Studies: A Deep Dive into 21 CFR Part 812

    Unlocking U.S. Clinical Studies: A Deep Dive into 21 CFR Part 812
    Aug 14 2025
    This episode demystifies the U.S. FDA's 21 CFR Part 812 regulation for Investigational Device Exemptions (IDEs). We explore the purpose of an IDE, the critical differences between significant and non-significant risk device studies, and the corresponding regulatory requirements for sponsors, investigators, and IRBs to ensure compliance during clinical trials. Key Questions: • What is an Investigational Device Exemption (IDE) and when is it required? • How does the FDA classify devices as Significant Risk (SR) versus Non-Significant Risk (NSR)? • What are the different approval pathways for SR and NSR device studies? • Who is responsible for determining the risk level of an investigational device? • What are the essential responsibilities of a sponsor during an IDE study? • What specific labeling is required for an investigational device? • How do regulations for informed consent and IRB review apply to IDEs? • What are the reporting requirements for adverse events during a clinical trial? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 m
  • Digital Compliance and Data Integrity: Mastering 21 CFR Part 11

    Digital Compliance and Data Integrity: Mastering 21 CFR Part 11
    Aug 13 2025
    This episode provides a comprehensive overview of the U.S. FDA's 21 CFR Part 11, detailing the essential compliance requirements for medical device companies using electronic records and signatures. We explore the core tenets of system validation, data integrity through audit trails, and the standards for legally binding electronic signatures, providing a clear roadmap for navigating this critical regulation. Key Questions: • What is 21 CFR Part 11 and when does it apply to a medical device company? • How can we ensure our electronic records are considered trustworthy and reliable by the FDA? • What are the specific requirements for system validation and access controls? • What makes an electronic signature compliant under Part 11? • Is a time-stamped audit trail required for all electronic records? • How did the FDA's guidance from August 2003 affect the interpretation of this rule? • What is the difference between relying on an electronic record versus a paper printout? • What three pieces of information must be associated with every electronic signature? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 m
  • FDA's New QMSR: Aligning with ISO 13485 and What It Means For You

    FDA's New QMSR: Aligning with ISO 13485 and What It Means For You
    Aug 12 2025
    This episode dives into the FDA's monumental shift from the Quality System Regulation (21 CFR Part 820) to the new Quality Management System Regulation (QMSR). We break down the incorporation of ISO 13485:2016, the critical effective date of February 2, 2026, and the specific additions and changes manufacturers must be aware of. We cover the new terminology, the integration of other FDA regulations, and the significant impact on inspections and risk management. Key Questions: • What is the new Quality Management System Regulation (QMSR)? • When does the new QMSR become mandatory? • How does the new rule incorporate ISO 13485:2016? • Are the Device Master Record (DMR) and Design History File (DHF) still required? • What key FDA regulations are now explicitly linked to the quality system? • Why are the new rules for labeling and packaging controls so important? • Are management review and internal audit records now subject to FDA inspection? • How does this change impact manufacturers who are not yet ISO 13485 certified? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 m
  • Decoding 21 CFR Part 814: A Guide to the FDA's Premarket Approval Pathway

    Decoding 21 CFR Part 814: A Guide to the FDA's Premarket Approval Pathway
    Aug 11 2025
    This episode provides a detailed overview of the FDA's Premarket Approval (PMA) process, governed by 21 CFR Part 814. We explore the requirements for Class III medical devices, the necessary components of a PMA submission, including non-clinical and clinical data, the FDA's review timeline and procedures, and the post-approval responsibilities of manufacturers. • What is a Premarket Approval (PMA) and which devices require it? • How does the FDA define a Class III medical device? • What are the essential components of a PMA application under 21 CFR Part 814? • What kind of data is required in the non-clinical and clinical study sections? • What is the FDA's 180-day review timeline for a PMA? • What are the possible outcomes of an FDA review? • What is a PMA supplement and when is it required? • What are a manufacturer's post-approval responsibilities? • Can the FDA withdraw a PMA approval after it has been granted? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    4 m