DocuRegs

At DocuRegs, we've been busy since the holidays and still going, preparing and creating insightful information for you. Our goal is to help you start 2024 armed with knowledge in MedTech regulatory, quality, and engineering. We've recently launched a YouTube channel featuring video content on, #PMCF #FDA predicate devices and classification #ISO13485 development #SupplierManagement #RiskAssessment #Vigilance, and more! ????????Please visit our channel, subscribe, share, and like to stay informed. ???????????????? ??-?????????? ???????????? ???????? ?????????????? ????????: ??"????????????????: ???????????????????? ???????????????????? ?????? ?????????????? ???????????? & ???????????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Leonard (Leo) Eisner Eisner, "The IEC60601 Guy." ??"???????????????????? ?????? ?????????? ?????????????? ???????????? ???????????????????? ??????????????????: ?? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Adam Isaacs Rae. ??"???????????????????? ?????? #SaMD ???????????????????? ????????: ?? ?????????????????????????? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Karandeep Singh Badwal. ??"Navigating the LATAM Regulatory Landscape: ?? ?????????????????????????? ?????????? ?????? ???????????????????? ?????????????? ??????????????????????????." Co-Authors: Mike B. Wetherington and Rishi Dewan MPharm, MSc, MTOPRA. At DocuRegs, our focus is on collaboration and contribution for the benefit of the community. If you have valuable insights on specific areas in #MedTech regulatory, quality, and engineering, we would love to hear from you. DocuRegs "???????????????? ????????????????????, ??????????????, ?????? ??????????????????????." ?? ??????-???????????? ??????????????????????. https://lnkd.in/gBK4ZzVW

How to prepare for QMSR with 10 simple questions. Ignoring these could cost you. The QMSR was published a year ago. But most MedTech companies still don’t know what they should be focusing on. That’s a problem. You might assume you’re fine right now. But a bad FDA inspection next year could prove otherwise. And by then, it’s too late. Here’s what you should be asking today: ?1. When does compliance become mandatory? ???→ Feb 2, 2026 ?2. What are the biggest changes? ???→ ISO 13485 alignment, including risk management ?3. How does this impact our current QMS? ???→ You won't know until you perform a gap analysis. ?4. Are DMR, DHF, and DHR still required? ???→ Yes, though the "official" names are changing. ?5. How will FDA inspections change? ???→ It's still TBD, but say goodbye to QSIT. ?6. What training does our team need? ???→ ISO 13485 requirements, at a minimum. ?7. How does this affect combination products? ???→ Minimally. CGMP requirements remain unchanged. ?8. Will this actually save us money? ???→ Anything's possible. It's fewer requirements to track? ?9. Does this help with global compliance? ???→ It could. ISO 13485 is the global QMS standard. 10. What resources can help us transition? ???→ Expect FDA guidance. Some day soon, we hope. QMSR may not require major changes for you. But assuming that without questioning is risky. The best way to prepare? → Start asking these questions. How is ???????? QMSR transition going?

One of the standout sessions at the 9th EAAR Annual Conference on Medical Device Regulations, held on February 24-25, 2025, in Brussels, featured Maria E. Donawa, M.D., addressing one of the most pressing challenges in regulatory compliance: meeting clinical data requirements under MDR and IVDR. ?? Check out this infographic for a visual breakdown, and read on for a summary of the key points: 1) The “Must-Haves” Before Starting a Clinical Investigation Conducting clinical studies is risky and expensive, and everyone involved, especially upper management, needs to understand what is needed. Maria emphasized the critical importance of sufficient staffing, understanding all relevant requirements, having biostatistical support and acceptable database management, and, above all, conforming to ISO 14155:2020. Without these elements, manufacturers risk regulatory delays, rejected submissions, and significant financial setbacks. ?? Clinical Benefit Requirements Many manufacturers struggle with understanding MDR requirements on clinical benefits, their overlap with clinical performance, and the need to clearly identify clinical benefits and related clinical outcome parameters (how they are evaluated or measured) in clinical evaluation plans. Making sure that clinical benefits can be clearly identified in clinical study protocols facilitates this process as vague or incomplete data won’t pass regulatory scrutiny. ?? EU vs. US: Key Regulatory Differences She highlighted a crucial distinction that affects global regulatory strategies when the same language is used in the EU and US. ?? If companies use “Indications for Use” or “Indications” in both the US and EU, it has been interpreted that there is a general Intended Purpose and medical conditions, which will need to be supported by clinical data. This is because the term “Indications” in the EU is interpreted to mean medical conditions. This impacts clinical data expectations, clinical study designs, and submission requirements, making early alignment and distinctions, where needed, between EU and US regulatory requirements and terminology essential. ? The Bottom Line: Knowledge and Precise Understanding are Key To meet EU and US clinical data requirements and expectations, manufacturers must: 1) Clearly understand the similarities and differences between these two jurisdictions 2) Ensure that internal staff are properly trained and knowledgeable on regulatory and clinical study requirements, and if necessary, supported by reliable external experts 3) Anticipate EU vs. US regulatory and clinical data differences to avoid compliance setbacks. The days of “we’ll figure it out later” are over—precision, strategy, and early planning are now essential for regulatory success. ?? Need expert guidance on clinical research and regulatory strategy? Donawa Lifescience specializes in clinical investigations, regulatory approvals, QMS compliance, and EU and US market access strategies.