QMS Auditing
QMSR
21 CFR 820, also known as the Quality Management System Regulation (the QMSR) 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 QMSR internal audits as well as a FDA Mock Inspection service, where an experienced consultant will take your company through the average 56 hour QMSR 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 medical devices, EU Class B, C, and D IVDs, 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 and IVD manufacturers distributing their products to the EU Member states. In order to maintain that certification, under MDR and IVDR, 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 MDR or IVDR compliance. Under the MDR and IVDR, there are many additional QMS requirements to be integrated into your Internal Audit program, and for you the legal manufacturer to have the documentary evidence of compliance.
For a quote on CRO Group CE Marking MDR/IVDR auditing services, click here.
MDSAP
MDSAP is the Medical Device Single Audit Program required for all Canadian Class II-IV medical device licenses. The FDA generally accepts recognized Auditing Organisations (AOs) MDSAP audit reports 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