Certifications | Quality Systems
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 digital health 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 a broad range of services to match your QSR need – from training, to internal and or supplier audits, to computer system (Part 11) validations, and design control supports.
To obtain a quote for CRO Group’s QSR related services click here.
ISO 13485:2016
ISO 13485:2016 is the current (required March, 2019) 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 and active implantables, and Annex II 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 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. Depending on the applicable regulation (MDR or IVDR) and product risk, the manufacturer may need to draw up and submit to technical documentation review by a Notified Body for the product family as an important part of meeting CE Marking requirements. The European QMS requirements coincide with those in the ISO 13485:2016 standard, but also include many “extras” – including for example, a procedure/process for filing Vigilance Reports, conducting Field Actions, Issuing Advisory Notices, and Post Market Surveillance. In addition, companies which already had a technical file or design dossier review under AIMD, MDD, or IVDD, need to get ready – the device and file are required to be re-reviewed under MDR or IVDR. Furthermore, if no file review was required under IVDD, there is a good chance under IVDR a Notified Body review will be required. This all makes now an excellent time to plan and implement your company’s MDR/IVDR compliance process.
For a quote on CRO Group CE Marking and MDR/IVDR consulting services, click here.
MDSAP
MDSAP (Medical Device Single Audit Program) is the QMS scheme replacing CMDCAS (Canadian Medical Device Conformity Assessment Scheme) for many medical device manufacturers. Most medical device manufacturers must be registered to the Canadian version of the ISO 13485 standard, by a MDSAP recognized Auditing Organization (AO) as a pre-requisite for product licensing. Health Canada “adds” to the ISO 13485 requirements (for example, implant registration cards when on the CMDR list). MDSAP AO’s are required to examine manufacturer’s ability to conform to the additional requirements as a criteria for issuing the ISO 13485/MDSAP audit report. Successful MDSAP can also reduce your FDA regular Inspection frequency (not including for-cause, follow-up or pre- or post-PMA approval). Australia, Brazil, and Japan all are participating in MDSAP and a successful MDSAP audit by a recognized AO can eliminate the QMS inspection requirements for that country.
For a quote on CRO Group’s MDSAP consulting services, click here