NJMEP can provide the tools and resources to help guide you through the complex tangle of regulations and standards your organization must meet to be compliant and competitive in a global market.
NJMEP can help you assess, comply, and train your organization to meet the ever-changing regulatory environment and remain profitable, efficient and successful.
In 2018 the FDA announced its intentions to harmonize the FDA Quality System Regulations [QSR] Title 21 CFR Part 820 cGMP with ISO 13485:2016. The move supports their participation in the global Medical Device Single Audit Program [MDSAP] and as a participant in the Global Harmonization Task Force [GHTF]. NJMEP Subject Matter Experts and Resources understand the new requirements and can help define and measure your compliance through our Gap Analysis program.
Fast becoming the standard for all Medical Device Manufacturers, ISO 13485:2016 incorporates risk management, continuous improvement, and process validation into the Quality Management System [QMS] that meets regulatory requirements on a global scale. For those suppliers currently marketing in the European Union under the Medical Device Directive compliance to ISO 13485:2016 is required for meeting the Medical Device Regulation 745 / 2017 that takes effect in 2021. NJMEP can provide your organization an overview of the standard and through our Gap Analysis program a roadmap to compliance and certification.
MedAccred is an industry managed supply chain accreditation program that reduces risk to patient safety and assures product quality and compliance with a set or standards focused on critical processes used in the production of medical devices. NJMEP can provide pre-audit assessment and gap analysis for those organizations who are key suppliers to the major OEMs who created and are promoting the program.