Certifications | Quality Systems
21 CFR 820, also known as the Quality System Regulation (the QSR) applies to companies in the USA and abroad, selling 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 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.
ISO13485 is the 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 or 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 preparation leading to registration as well as support in maintaining registration. To obtain a quote for ISO 13485 services, click here
EU MDD and IVDD
CE Marking requires quality systems certification for most medical device manufacturers. Depending on the applicable directive (The Medical Device Directive or In Vitro Diagnostic Directive), there can be up to 4 Quality System certifications leading to CE Marking. The most popular Certifications for the MDD are Annex II – Full Quality System, and Annex V – Production Quality System – when the manufacturer is not responsible for design controls. For each of the certifications, the manufacturer may need to draw up and submit a technical file or design dossier for the product family in addition to meeting the European QMS requirements. The European QMS requirements, while largely the same as that as contained in ISO 13485, include a few “extras” – including for example, a procedure for filing EU Vigilance Reports as well as conducting EU Field Actions.
For a quote on CRO Group CE Marking and MDD/IVDD consulting services, click here.
CMDCAS is the Canadian Medical Device Conformity Assessment Scheme for quality systems for medical device manufacturers. Most medical device manufacturers must be registered to the Canadian version of the ISO 13485:2003 standard, by a CMDCAS recognized Registrar as a pre-requisite for product licensing. Health Canada “adds” to the ISO 13485 requirements in several clauses throughout the standard. CMDCAS registrars are required to examine manufacturer’s ability to conform to the additional requirements as a criteria for issuing the ISO 13485/CMDCAS certificate.
For a quote on CRO Group’s CMDCAS and CMDR (Canadian Medical Device Regulation) consulting services, click here