Reglera Achieves ISO Certificate for Medical Device Quality Management Systems
Reglera is a leading organization specializing in quality and regulatory consulting and process outsourcing. Reglera focuses on two primary industries: medical devices and human cellular and tissue products. Since 1999, Reglera has been helping tissue and medical device companies navigate the regulatory maze through its expertise and understanding of regulatory and quality systems requirements.
Based in Lakewood, CO, Reglera is recognized as one of the largest and fastest growing regulatory consulting and outsourcing companies in the world. With more than 100 employees worldwide, and an unmatched group of strategic partners, Reglera is uniquely positioned to provide companies with products and services covering a wide variety of technical and support areas. Our fixed bid pricing approach is unique to our industry and provides significant benefits to our clients.
Whether you are developing a new product, improving an existing product, need assistance with the FDA, or are simply trying to comply with the myriad of regulation and standards, Reglera's products and services will accelerate your success and profitability. If the right regulatory partner for your company is one that not only advises, but also specializes in implementation and results, choose Reglera. Our combination of regulatory expertise and operational knowledge will accelerate your products to market and ensure compliance and operational efficiency. In addition, all of our products and services come with the guarantee that if you receive any FDA observations, we will respond to the FDA and correct the issue and at no charge to you.
ISO Certifications
Reglera’s quality management system has been certified to ISO 13485:2003 and to ISO 9001:2008 by notified body BSI.
ISO 13485:2003 and 9001:2008 are international quality standards for medical devices and device suppliers. Technical committees comprised of members from many national standards organizations develop ISO standards. Consequently, companies awarded these ISO standard certifications are internationally recognized as upholding ISO’s superlative quality standards in their own quality systems.
This standard certification is normally awarded to medical device manufacturers; however, because Reglera’s outsourced products (such as a Document Control and Training program, and a Donor Eligibility Determination System) handle elements of the manufacturing process for our clients, Reglera is one of the first consulting companies able to qualify for such certifications.
