The pharmaceutical and biotechnology sectors operate in highly regulated environments, where compliance with international standards is essential for ensuring product safety and efficacy. Recent updates to ISO standards reflect the evolving regulatory landscape and emphasize critical areas such as biocompatibility and data security. Staying informed on these changes is vital for companies aiming to remain compliant and competitive.
ISO 10993-17:2023 – Enhancing Medical Device Biocompatibility
The most recent update to the ISO 10993-17:2023Â standard has introduced significant improvements to medical device biocompatibility evaluations, with a focus on toxicological risk assessments. This update is particularly relevant for companies developing combination products, such as drug-device hybrids. The recent revision highlights the importance of assessing toxicological thresholds and setting risk acceptance criteria for materials that interact with biological tissues. This ensures that the materials used in drug-delivery systems or medical devices are safe for patient use over time.
ISO 27001 – Information Security in the Digital Age
As the pharmaceutical and biotech industries continue to digitalize, ISO 27001Â has gained prominence as the international standard for information security management systems (ISMS). The standard emphasizes safeguarding sensitive data, including proprietary research, patient health information, and intellectual property. This has become especially crucial in light of increasing cybersecurity threats. Compliance with ISO 27001 ensures that companies protect their data assets while meeting regulatory requirements for data privacy.
Conclusion
Staying abreast of ISO updates is essential for ensuring safety, compliance, and operational efficiency. At Boston Biotech Advisors, we offer expert guidance on navigating these evolving standards. Contact us by email at info@bostonbiotechadvisors.com to learn how we can help your company stay ahead of regulatory changes.
