Reglera, one of the regulatory compliance and quality assurance consulting and outsourcing companies for Medical Device and Tissue Bank organizations, has become a Parametric Technology Corporation (PTC) Strategic Services Partner (SSP).
Reglera is expected to offer configuration, implementation and training for PTC’s integrated product life cycle management (PLM) and quality management system (QMS) solutions sold in the medical device industry.
As a SSP, Reglera will leverage its regulatory and QMS expertise and integration / validation experience with PTC’s Windchill and NetRegulus software solutions to deliver clients industry proven best-practices PLM/QMS configurations.
Having the capability to align client needs with a menu of Reglera’s ‘best-practice’ configurations will reduce implementation time and ensure clients the most cost-effective, validated solution compliant with FDA regulations 21 CFR parts 820, 1271 and 11 and applicable ISO standards, said the company.
Clay Anselmo, president and CEO of Reglera, said: “In evaluating the Medical Device marketplace, regulated companies have consistently told us that in the arena of software/systems, one of their ongoing problems is that software companies typically utilize implementation resources with technical software knowledge but with very little, or no, regulatory compliance or quality assurance domain expertise.
“Without exception, this translates into long and/or failed implementations, inefficiently configured systems, increased costs, and possible quality problems leading to increased regulatory risks.”