European and International standards

  Navigating Enhanced Safety: The New Standard for Medical Packaging - EN ISO 11607-1:2020/A1:2023 Published on February 19, 2024, the latest amendment to the EN ISO 11607-1:2020 standard, specifically A1:2023, marks a significant advancement in the packaging of terminally sterilized medical devices. This update introduces a focused approach to risk management within the packaging processes, ensuring that safety remains paramount from the manufacturing floor to the operating table. The amendment outlines refined requirements for materials, sterile barrier systems, and packaging systems, integrating a more comprehensive application of risk management principles. For manufacturers and healthcare providers, this means adhering to more stringent controls and demonstrating compliance through detailed risk analysis and mitigation strategies. This shift not only aims to enhance the protective quality and integrity of medical packaging but also aligns with global regulatory expectations, f...

  The Ecodesign for Sustainable Products Regulation (ESPR) is a significant legislative framework proposed by the European Commission aimed at making products sold in the EU market more sustainable. This regulation builds upon the existing Ecodesign Directive, which primarily targeted energy-related products, and extends the scope to cover a broader range of products with the objective of reducing environmental impact throughout their lifecycle. Key Objectives of the ESPR Broadening Product Scope : Unlike its predecessor, the ESPR is designed to cover a wide array of products, not just those that consume energy. It includes textiles, furniture, steel, cement, and chemicals, focusing on the entire lifecycle of the products—from production to disposal. Product Passports : One of the innovative features of the ESPR is the introduction of digital product passports. These passports are intended to provide detailed information about a product’s origin, composition, and end-of-life handl...

  The Importance of ISO 13485:2016 for Medical Device Companies In the rapidly evolving medical device industry, maintaining the highest standards of quality is not just beneficial—it's mandatory. ISO 13485:2016, officially known as "Medical devices - Quality management systems - Requirements for regulatory purposes," serves as a critical framework for ensuring quality assurance throughout the lifecycle of medical devices. This standard is tailor-made to help organizations consistently meet customer requirements and adhere to stringent regulatory laws. What is ISO 13485:2016? ISO 13485:2016 outlines the requirements for a comprehensive quality management system (QMS) specific to the medical device industry. It focuses on the safety and efficacy of devices throughout their design, manufacture, and deployment phases. The standard is utilized globally by manufacturers, suppliers, and service providers within the medical device sector. Key Components of ISO 13485:2016 Compre...