Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on making your products the best they can be. SAXOCON is ISO 13485 certified, allowing us to function as a plug-and-play partner to help you develop high-quality products.
In the EU, Pharmaceutical manufacturers must adhere to Good manufacturing practice (GMP) guidelines. GMP compliance ensures that medical products are produced consistently and controlled for quality to ensure their safety and effectiveness. These guidelines are not prescriptive, so the individual manufacturer is responsible for designing a quality system that ensures product quality, from raw materials to final finished product.
EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 cover medical devices and require manufacturers to demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These regulations hold manufacturers fully responsible for all outsourced processes. Fulfilling this obligation requires understanding and monitoring every aspect of the supply chain, including the materials used, the impacts manufacturing processes can have on final products, and whether any impurities found in the materials used can affect end users. The state-of-the-art practice for medical device manufacturers in the EU and US is adherence to the quality management systems standard from ISO 13485:2016.
As a manufacturer, having confidence in your suppliers lets you focus on making your manufacturing processes and products safe and compliant so they can be approved and ready for market as quickly as possible. Since 2021, SAXOCON has been ISO 13485 certified, allowing us to serve as a critical supplier of toxicological evaluation services. Our quality management system ensures we have the right resources, competencies, procedures, and processes to provide consistent and quality-controlled services. Using us as a supplier of high-quality toxicological services gives you peace of mind and one less thing to worry about at your next audit.
For us as a consultancy, ISO 13485 certification is our version of GMP. Getting certified is not a one-off event, and our processes are audited regularly to ensure they remain compliant. Therefore, we are committed to continually investing in, developing, and improving our quality management system.
Learn more about how our certified services can support your business below:
Medical device manufacturers
Pharmaceutical manufacturers