https://bioexcelife.com/insights Clinical, regulatory and scientific insights from Bioexcel. en-us https://bioexcelife.com/insights/performance-evaluation-under-ivdr-explained-2 https://bioexcelife.com/insights/performance-evaluation-under-ivdr-explained-2 Wed, 23 Sep 2026 00:00:00 GMT Performance evaluation is one of the most important requirements for IVD manufacturers under the EU IVDR. Under the In Vitro Diagnostic Medical Devices Regulation, manufacturers… https://bioexcelife.com/insights/why-spreadsheets-break-down-during-mdr-audits-2 https://bioexcelife.com/insights/why-spreadsheets-break-down-during-mdr-audits-2 Wed, 16 Sep 2026 00:00:00 GMT Spreadsheets are simple. They are familiar. They are easy to start with. That is why many medical device companies still use them for PMS tracking, complaint logs, CAPA actions,… https://bioexcelife.com/insights/what-is-permitted-daily-exposure-pde https://bioexcelife.com/insights/what-is-permitted-daily-exposure-pde Wed, 09 Sep 2026 00:00:00 GMT In pharmaceutical and medical device manufacturing, patient safety does not end with the final product. It also depends on how well manufacturers control residues, impurities,… https://bioexcelife.com/insights/why-spreadsheets-break-down-during-mdr-audits https://bioexcelife.com/insights/why-spreadsheets-break-down-during-mdr-audits Wed, 02 Sep 2026 00:00:00 GMT Spreadsheets are simple. They are familiar. They are easy to start with. That is why many medical device companies still use them to manage PMS trackers, complaint logs, CAPA… https://bioexcelife.com/insights/toxicological-risk-assessment https://bioexcelife.com/insights/toxicological-risk-assessment Wed, 26 Aug 2026 00:00:00 GMT In medical device and pharmaceutical compliance, safety cannot be based on guesswork. Every chemical, residue, impurity, extractable, or leachable has the potential to create risk… https://bioexcelife.com/insights/toxicological-risk-assessment-why-it-matters https://bioexcelife.com/insights/toxicological-risk-assessment-why-it-matters Wed, 19 Aug 2026 00:00:00 GMT In medical device and pharmaceutical compliance, safety cannot depend on assumptions. It must be supported by strong scientific evidence. This is where Toxicological Risk… https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers-3 https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers-3 Wed, 12 Aug 2026 00:00:00 GMT Biological safety is one of the most important parts of medical device compliance under EU MDR. If a device comes into direct or indirect contact with the human body,… https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers-2 https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers-2 Wed, 22 Jul 2026 00:00:00 GMT Biological safety is one of the most important parts of medical device compliance under EU MDR. If a medical device comes into direct or indirect contact with the human body,… https://bioexcelife.com/insights/ivdr-compliance-starts-with-strong-performance-evaluation https://bioexcelife.com/insights/ivdr-compliance-starts-with-strong-performance-evaluation Wed, 15 Jul 2026 00:00:00 GMT Performance evaluation is one of the most important requirements for IVD manufacturers under the EU IVDR. Under the In Vitro Diagnostic Medical Devices Regulation, manufacturers… https://bioexcelife.com/insights/cer-nonconformities-raised-by-notified-bodies https://bioexcelife.com/insights/cer-nonconformities-raised-by-notified-bodies Wed, 01 Jul 2026 00:00:00 GMT A Clinical Evaluation Report may look complete. It may have literature, PMS data, device details, and a benefit-risk conclusion. But still, a Notified Body may raise questions.… https://bioexcelife.com/insights/what-is-a-toxicological-risk-assessment-tra https://bioexcelife.com/insights/what-is-a-toxicological-risk-assessment-tra Wed, 24 Jun 2026 00:00:00 GMT In regulated industries, safety is not based on assumptions. It must be supported by science. This is where a Toxicological Risk Assessment , or TRA , becomes important. A TRA is… https://bioexcelife.com/insights/permitted-daily-exposure-why-pde-matters-in-patient-safety https://bioexcelife.com/insights/permitted-daily-exposure-why-pde-matters-in-patient-safety Wed, 17 Jun 2026 00:00:00 GMT Permitted Daily Exposure, also known as PDE, is an important safety limit used in pharmaceutical and medical device manufacturing. It helps define how much of a substance a… https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers https://bioexcelife.com/insights/iso-10993-explained-for-mdr-manufacturers Wed, 10 Jun 2026 00:00:00 GMT Biological safety is one of the most important parts of medical device compliance under EU MDR. If your device comes into direct or indirect contact with the human body,… https://bioexcelife.com/insights/performance-evaluation-under-ivdr-explained https://bioexcelife.com/insights/performance-evaluation-under-ivdr-explained Wed, 03 Jun 2026 00:00:00 GMT Performance evaluation is one of the most important requirements for IVD manufacturers under the In Vitro Diagnostic Medical Devices Regulation (IVDR) . Under IVDR , manufacturers… https://bioexcelife.com/insights/oel-vs-pde-understanding-exposure-limits-in-pharma-and-medical-device-safety https://bioexcelife.com/insights/oel-vs-pde-understanding-exposure-limits-in-pharma-and-medical-device-safety Wed, 27 May 2026 00:00:00 GMT In pharmaceutical and medical device manufacturing, safety does not stop at product quality. It also includes protecting workers, patients, and manufacturing environments from… https://bioexcelife.com/insights/per-vs-cer-what-changes-for-ivd-manufacturers https://bioexcelife.com/insights/per-vs-cer-what-changes-for-ivd-manufacturers Wed, 20 May 2026 00:00:00 GMT For many medical device teams, CER is a familiar term. But for IVD manufacturers under the EU IVDR , the focus shifts from a Clinical Evaluation Report (CER) to a Performance… https://bioexcelife.com/insights/why-spreadsheets-fail-during-mdr-audits https://bioexcelife.com/insights/why-spreadsheets-fail-during-mdr-audits Wed, 13 May 2026 00:00:00 GMT Spreadsheets are easy to start with. They are familiar, flexible, and quick to use. That is why many medical device companies still use them to manage regulatory data, PMS… https://bioexcelife.com/insights/connecting-clinical-evidence-pms-risk-management-the-key-to-stronger-medical-device-compliance https://bioexcelife.com/insights/connecting-clinical-evidence-pms-risk-management-the-key-to-stronger-medical-device-compliance Wed, 06 May 2026 00:00:00 GMT In medical device regulation, clinical evidence, Post-Market Surveillance, and risk management are often treated as separate activities. But under today’s regulatory expectations,… https://bioexcelife.com/insights/eudamed-more-than-a-database-the-core-of-eu-mdr-compliance https://bioexcelife.com/insights/eudamed-more-than-a-database-the-core-of-eu-mdr-compliance Wed, 29 Apr 2026 00:00:00 GMT Most professionals still think of EUDAMED as a place to upload data. That’s not the full picture. EUDAMED is evolving into the central system that connects the entire medical… https://bioexcelife.com/insights/mdcg-2021-24-rev-1-key-updates-in-medical-device-classification-under-eu-mdr https://bioexcelife.com/insights/mdcg-2021-24-rev-1-key-updates-in-medical-device-classification-under-eu-mdr Wed, 22 Apr 2026 00:00:00 GMT Many manufacturers assume device classification is settled once the first rationale is written. That assumption can become risky. In April 2026 , the Medical Device Coordination… https://bioexcelife.com/insights/imdrfs-new-ai-ml-lifecycle-draft-could-reshape-global-medtech-compliance https://bioexcelife.com/insights/imdrfs-new-ai-ml-lifecycle-draft-could-reshape-global-medtech-compliance Wed, 15 Apr 2026 00:00:00 GMT AI in healthcare is no longer just about innovation. It is now about governance, traceability, and long-term control. That is why the new draft from the International Medical… https://bioexcelife.com/insights/eu-mdr-ivdr-certifications-what-the-2026-notified-body-survey-reveals https://bioexcelife.com/insights/eu-mdr-ivdr-certifications-what-the-2026-notified-body-survey-reveals Wed, 08 Apr 2026 00:00:00 GMT If you think getting CE certification is just a process—think again. The latest EU Notified Bodies Survey 2026 reveals a growing challenge in the medical device industry: more… https://bioexcelife.com/insights/cdsco-update-on-ivf-and-art-medical-devices https://bioexcelife.com/insights/cdsco-update-on-ivf-and-art-medical-devices Wed, 01 Apr 2026 00:00:00 GMT India’s fertility care sector is growing fast. However, with that growth comes stronger regulatory oversight. In a recent circular, the Central Drugs Standard Control Organisation… https://bioexcelife.com/insights/what-notified-bodies-expect-in-a-cer-under-eu-mdr https://bioexcelife.com/insights/what-notified-bodies-expect-in-a-cer-under-eu-mdr Fri, 27 Mar 2026 00:00:00 GMT Most manufacturers believe their CER is ready until the Notified Body starts asking questions. And that’s where the reality of EU MDR hits. A Clinical Evaluation Report today is… https://bioexcelife.com/insights/ivdr-performance-evaluation-nb-review-explained https://bioexcelife.com/insights/ivdr-performance-evaluation-nb-review-explained Tue, 13 Jan 2026 00:00:00 GMT Introduction: Why Performance Evaluation Is Where IVDR Decisions Are Made Many IVD manufacturers assume that once performance studies are completed, regulatory approval is largely… https://bioexcelife.com/insights/indias-medical-device-industry-scheme https://bioexcelife.com/insights/indias-medical-device-industry-scheme Wed, 07 Jan 2026 00:00:00 GMT Introduction: A Game-Changer for India’s MedTech Sector The Indian government’s Scheme for Strengthening of the Medical Device Industry is a landmark initiative designed to boost… https://bioexcelife.com/insights/why-ivdr-performance-studies-fail-during-review https://bioexcelife.com/insights/why-ivdr-performance-studies-fail-during-review Wed, 07 Jan 2026 00:00:00 GMT Introduction: When Study Completion Isn’t the Finish Line For many IVD manufacturers, completing a performance study feels like crossing a major regulatory milestone. Budgets are… https://bioexcelife.com/insights/clinical-trials-for-medical-devices-under-eu-mdr https://bioexcelife.com/insights/clinical-trials-for-medical-devices-under-eu-mdr Wed, 24 Dec 2025 00:00:00 GMT Introduction: Why Clinical Trials Have Become a Bottleneck for CE Marking For many medical device manufacturers, CE marking under the EU MDR has become slower, costlier, and far… https://bioexcelife.com/insights/mdcg-2025-9-eu-guidance-on-breakthrough-devices https://bioexcelife.com/insights/mdcg-2025-9-eu-guidance-on-breakthrough-devices Wed, 17 Dec 2025 00:00:00 GMT In 2025, the Medical Device Coordination Group (MDCG) released MDCG 2025-9 , a new guidance introducing a structured EU framework for Breakthrough Devices (BtX) under EU MDR… https://bioexcelife.com/insights/indias-new-cdsco-risk-classification-update https://bioexcelife.com/insights/indias-new-cdsco-risk-classification-update Wed, 10 Dec 2025 00:00:00 GMT The Central Drugs Standard Control Organisation (CDSCO) has released a new circular announcing the launch of the Risk Classification Module on the Online Medical Device System…