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. Every product that we make is the very best of its kind.
- ISO 9001:2000 Registered
- ISO 13485:2003 Medical Device Regulations
- CE Mark Certified
- PAL Accreditation No. BG30400220
- FDA Registered
- Our Customers
- Anthrax Testing
- Environmental Partnerships
ISO 9001:2000 Registered
To achieve ISO 9001:2000 certification by the International Organization for Standardization — 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 an onsite audit of the company’s manufacturing processes to determine if it is in compliance with that industry’s best practices.
Puritan is ISO 9001:2000 registered, and all production comes under the most stringent quality controls.
ISO 13485:2003 Medical Device Regulations
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.
CE Mark Certified
It is accurate to state that our medical products carry the CE mark; CE mark refers to product compliance rather than facility or quality system compliance. BSI certifies the sterility of the medical device line, and Puritan self declares CE compliance of the non-sterile line of medical devices.
PAL Accreditation No. BG30400220
It is accurate to state that we are registered with the Japan’s Minister of Health, Labour and Welfare (MHLW), an organization equivalent to the U.S. Food and Drug Administration, and comply with the PAL regulations. Regulatory agencies do not “approve” devices or drugs or manufacturers.
FDA Registered
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.
Our Customers
Leading national medical distributors, whose products are found in hospitals, emergency rooms, and treatment rooms across the country, partner with us for their many private-label products. As a medical products company we manufacture proprietary applicators and provide specially packaged first aid supplies and promotional products for the major diagnostic and pharmaceutical companies in the U.S. and abroad.
Anthrax Testing
U.S. diagnostic companies are working hard to meet the challenge presented by the pressing need to wage a war against bioterrorism. Puritan Medical Products Company works closely with this industry in the development of swabs for tests being designed for the rapid detection of pathogens such as anthrax.
Environmental Partnerships
Puritan and its suppliers support responsible forestry practices and are signatories to certification programs such as The Sustainable Forestry Initiative and the Chain of Custody program. We value our country’s environmental heritage and are committed to doing our part to assure that our forests, lakes, and streams are here for the enjoyment of generations to come.
