Medical Device Manufacturing
MEDICAL DEVICE MANUFACTURING – NEW JERSEY TRAINING & CONSULTING
The New Jersey Manufacturing Extension Program (NJMEP) is dedicated to helping Medical Device Manufacturers be successful, efficient, and profitable. This includes their component suppliers and Contract Manufacturing Organizations [CMO], who in the view of the FDA, must also meet the same current Good Manufacturing Practices [cGMP].
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.
cGMP (Current Good Manufacturing Practices)
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.
ISO 13485: 2016
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
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.
