All of our products come backed with the Puritan promise of quality. Our manufacturing facility is ISO certified and CE mark registered, so you can be certain we always adhere to the strictest quality guidelines. In fact, we regularly go beyond for our own QC satisfaction. It is very important to us that every product we make is the best of its kind.
To achieve ISO 9001:2008 certification to the management system standards set by the International Organization for Standardization (link to iso.org) — a worldwide governing body — a company must demonstrate that it has an effective quality assurance system that satisfies all the required applicable industry standards. An external auditor, or registrar, conducts on-site audits of the company’s manufacturing processes to determine if it is in compliance with that industry’s best practices.
Puritan is ISO 9001:2008 registered, and all production comes under the most stringent quality controls. FM 31363 ISO Certification
ISO 13485 is the ISO 9000 for medical device manufacturers. Embracing the FDA’s good manufacturing practices, this standard defines terms such as medical device, active medical device, active implanted medical device, sterile medical device, and more. This international standard specifies requirements for a quality-management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. FM 75992 13485 Certification
Puritan is proud to state that our medical products carry the CE mark; CE mark refers to product compliance rather than facility or quality system compliance. The British Standards Institution (BSI) certifies the sterility of the medical device line, and Puritan self-declares CE compliance of the non-sterile line of medical devices. CE Mark Certification
It is accurate to state that we are registered with Japan’s Ministry of Health, Labour and Welfare (MHLW), an organization equivalent to the U.S. Food and Drug Administration, and we comply with Japan’s Pharmaceutical Affairs Law (PAL) regulations. Regulatory agencies do not “approve” devices or drugs or manufacturers. View certificate here.
Puritan brand products are manufactured under FDA requirements for medical devices. Our Quality Systems conform to the Food and Drug Administration’s Good Manufacturing Practices (GMPs).
Our quality control procedures include verification and documentation of raw materials and machine settings and visual examinations of finished goods for correct raw materials, labels, packaging, dimensions, contamination, and tip adhesion. Results are documented, and records are maintained for five years. If you have questions about any of our credentials or certificates, please contact us. A customer service professional will be happy to assist you.