Boston BioProducts establishes the ability to meet medical device quality requirements under ISO 13485:2016
MILFORD, Mass.——Boston BioProducts, a longstanding manufacturer of fundamental reagents for the life sciences, today announced that its quality management system (QMS) has achieved ISO 13485:2016 certification from TÜV SÜD America for the medical device manufacturing and supply of buffers, solutions, media, and reagents serving research, diagnostics, and therapeutics applications. Achieving this certification signifies Boston BioProducts’ commitment to high-quality standards across the entire reagent manufacturing process.
ISO 13485:2016 is considered the industry standard for QMS systems designed for medical devices and related services. It sets a robust and reproducible framework for the design, development, and manufacturing of products that meets customer and regulatory requirements. The International Organization for Standardization (ISO) is a global, independent publisher of standards governing the safety, reliability, and quality of manufactured products. TÜV SÜD America is among the most respected and accomplished certification bodies in the market serving thousands of registrations worldwide.
“This major company milestone further supports Boston BioProducts’ path to becoming a premier partner for contract reagent development and manufacturing across research, diagnostics, and therapeutics”, said Neil Sharma, General Manager of Boston BioProducts. “Scientists, assay developers, and manufacturing engineers can rely on a single source for the customization, testing, and supply of their process-critical buffers, solutions, and media reagents whether starting from innovation to publication, RUO to IVD, or preclinical to GMP.”
With the ISO 13485:2016 certification, Boston BioProducts is better positioned to support a range of growing regulated applications such as in vitro diagnostics, clinical trial assays, and cell and gene therapy manufacturing. This elevated quality management system complements the company’s flexible custom reagent manufacturing and rapid product delivery.
About Boston BioProducts
For nearly 30 years, Boston BioProducts (BBP) has manufactured and supplied fundamental reagents (buffers, solutions, media, and more) to researchers, diagnostic and technology platforms, and drug developers worldwide. With its custom reagent manufacturing services, BBP becomes an extension of your lab with flexible parameters to design the ideal research and manufacturing tools. Its mission is to increase the reproducibility of product- and process-critical reagents that keep your science consistent and moving forward. For more information, please visit www.bostonbioproducts.com and follow us on LinkedIn.