Reglera Adds Contract Manufacturing to its Service Portfolio

Reglera LLC, a provider of regulatory, quality assurance and process outsourcing consulting services to medical device firms, is taking its reach one step further. The company now will offer outsourcing manufacturing services to help medical device companies bring products to market more cost-effectively. Reglera has added contract manufacturing to its range of services offered, including the production of early prototypes, validation and clinical trial units, and first commercial products.

In addition to offices in Israel, the company has a new manufacturing facility in Wheat Ridge, Colo., which is where its United States headquarters are located. There, Reglera can manufacture both disposable medical products and electromechanical mechanical devices. The service will be conducted under Reglera’s ISO 13485 certified quality system implying clients can expect high-quality products that meet all regulatory requirements. The company has been certified to ISO 13485:2003, which certifies that a company has comprehensive management system for the design and manufacture of medical devices, and ISO 9001:2008, a certification for quality management.

In its outsourcing programs, Reglera assumes responsibility for the execution of functions such as document control, training, complaint handling, audits and now contract manufacturing. According to the company, contract manufacturing was an added service requested by existing customers.

“This natural expansion of our service offering is being introduced to address a common need of medical device companies during their product development cycle. It is positioning Reglera in an even better place to deliver value to our existing and future clients as a one-stop service provider for the medical device industry worldwide,” said Clay Anselmo, Reglera CEO and president.

Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries worldwide.