NuMED is an Accredited Organization
NuMED is an Accredited Organization and complies with the ISO 13485:2016 standard. The valid certificates attest to our recognition in designing and manufacturing quality products.
Quality Management System Accreditation
NuMED’s Quality Management System is focused on meeting customer needs in compliance with both domestic and international regulations and standards. All manufacturing is conducted in compliance with applicable Quality System (QSR) requirements.
Our Quality Manual and Administrative Procedures are key components of our Quality System. Internal Audits and Management Reviews are conducted annually and ensures continual improvement of our Quality System, as well as adherence to both FDA and ISO requirements. Quality meetings are also held monthly to review all aspects of the Quality System.
Annual Audits Ensure Compliance to MDSAP Regulations
NuMED is audited annually for compliance to MDSAP Regulations. This includes:
● BS EN ISO 13485: 2016, Medical Devices – Quality Management System – Requirements for Regulatory Purposes,
● Canadian Medical Device Regulations (SOR /98-282),
● US FDA’s 21 CFR (Parts 801, 803, 806, 807, 812, 814, 820, 821, 822, 830, 860, 870 and 886) of the Federal Food, Drug and Cosmetic Act,
● European Regulation (EU) 2017/745,
● Europe’s Council Directive 93/42/EEC, of June 14, 1993 concerning Medical Devices (MDD), as amended by Directive 2007/47/EC,
● Australian Therapeutic Goods (Medical Devices) Regulation (Schedule 3),
● Brazilian Good Manufacturing Practices (ANVISA RDC No. 665/2022, 551/2021, and 67/2009), and
● Japanese QMS Ordinance (MHLW MO 169) and PMD Act.
The combined certificates for NuMED, Inc. and NuMED Canada, Inc. are available below.
