QMS Auditing
QSR
21 CFR 820, also known as the Quality System Regulation (the QSR) applies to companies in the USA and abroad, marketing and distributing medical device products (including many web and mobile apps) in the USA. Over the past few years, FDA has stepped up its inspection program for developers and manufacturers resulting in more FDA-483 Inspection Observations, and, more often than not, in Warning Letters if not responded to in a timely and comprehensive manner. CRO Group offers both routine QSR internal audits as well as a FDA Mock Inspection service, where an experienced consultant will take your company through the average 56 hour QSR inspection in between 12 and 36 hours, and cover the applicable inspection modules in FDA’s Compliance Guide. To obtain a quote for CRO Group’s QSR internal audit or Mock Inspection services click here.
ISO 13485:2016
ISO 13485:2016 is the latest International Standard for Quality Management Systems for medical device developers, manufacturers and distributors as well as support organizations such as biomedical engineering service and installation companies. It is recognized and is often required for higher risk medical devices in most countries and regions such as the USA, Canada, the EU, Japan, and Australia. Certification to the standard is required for CE Marking for EU Class I-M, I-S, IIA, IIB, and III devices, and Canadian Class II through IV product licensing. There is also a growing demand for manufacturer support organizations to maintain registration as part of their relationship with the manufacturers who use them for local service, installation, training, etc. The CRO Group specializes in turnkey ISO 13485:2016 preparation leading to registration as well as support in maintaining registration. To obtain a quote for ISO 13485 services, click here
EU MDR and IVDR
CE Marking requires quality systems certification for most medical device manufacturers. In order to maintain that certification, under AIMD, MDD, or IVDD, Notified Bodies expect Internal Audits by a Qualified Expert. CRO Group consultants also subcontract with Notified Bodies – which means we have the expertise. In addition, Notified Bodies may expect that your critical suppliers are audited for AIMD/MDD/IVDD compliance. And it’s only going to get more intense – Under the MDR and IVDR, there are many additional QMS requirements to be integrated into your Internal Audit program. For a quote on CRO Group CE Marking and AIMD/MDD/IVDD and or MDR/IVDR auditing services, click here.
MDSAP
MDSAP is the Medical Device Single Audit Program developed by the IMDRF, and replacing CMDCAS (Canadian Medical Device Conformity Assessment Scheme) effective in 2019 in order to maintain Class II-IV medical device licenses. The FDA has confirmed that it will accept recognized Auditing Organisations (AOs) MDSAP audit report as a substitute for routine FDA inspections (“For Cause”, “Compliance Follow-up” as well as Pre-Approval and Post-Approval FDA Inspections are not eligible.) While there is no “MDSAP” Internal Audit requirements, many AO’s, as part of the MDSAP audit, expect Internal Audits to cover the applicable regulatory requirements of the countries (Australia, Brazil, Canada, Japan, and USA/FDA.) CRO Group consultants are qualified to conduct Internal Audits covering these regulatory requirements. For a quote on CRO Group’s MDSAP related auditing services, click here