Content by Grant Ramaley
The Role of International Accreditation in Management System CertificationThere’s a lot below the surface of an ISO QMS certificate
Thu, 03/07/2024 - 12:02
When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance. Our trust forms the backbone of what we expect from our food, cars,…
IAF CertSearch Team Identifies 20,000 Fake or Fraudulent ISO QMS CertsIAF CertSearch now mandatory for accredited certification bodies
Mon, 04/03/2023 - 12:02
As of 2023, more than 27,000 medical device QMS certificates have been issued worldwide, providing confidence in medical devices. From cardiac stents to simple dental tools used to correct teeth, the healthcare systems of the world have come to rely…
It’s Time for the FDA to Fully Embrace ISO 13485FDA seeks to align Part 820 with ISO 13485:2016; why that may not be enough.
Tue, 08/16/2022 - 12:03
The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485. But by 2003,…
Shifting Auditor Competency in the Supply Chain: The Impact of New IAF MD9:2022 Medical device regulators and the medical device industry will benefit from the added confidence
Tue, 02/15/2022 - 12:03
The IAF Medical Device Working Group has updated one of the most important documents that supports the medical device quality system ISO 13485. IAF MD9:2022—“Application of ISO/IEC 17021-1 in the field of medical device quality management systems (…
The Currency of Credibility: Valid ISO Certification According to ISOVerify ISO QMS certificates using the International Accreditation Forum (IAF) CertSearch database
Thu, 01/21/2021 - 12:02
As the 2020 pandemic threatened world health, a large number of unscrupulous companies began generating fake International Organization for Standardization (ISO) quality management system (QMS) certificates in an attempt to fool governments into…
IEC 60601-1:2020 Edition 3.2 Launches. Prepare for Impact!Edition 3.2 compliance costs will likely create major challenges for manufacturers of medical electrical devices
Tue, 11/03/2020 - 12:03
IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some…
Possible Cure for Outbreak of Fake Certificates From Covid-19 PandemicThe IAF certification database could help confirm the quality of medical purchases by governments
Thu, 05/28/2020 - 12:01
The International Accreditation Forum (IAF), the association of conformity assessment accreditation bodies worldwide, held an emergency meeting after confirming what appears to be an outbreak in the use of fake ISO 13485 certificates. ISO 13485 is a…
Will New EU Medical Device Regulation Hit Tongue Depressors Before Defibrillators? European MDR update: Lowest risk medical devices must comply by May 26, 2020
Tue, 07/02/2019 - 12:03
Although the “new approach” to regulating medical devices has always given more urgency to higher-risk medical devices, this is not the case for the European Medical Device Regulation (MDR). Class 1 medical devices must fully comply with the…
MDSAP: When Is a Certificate Not a Certificate?The quiet battle over medical device trade in Canada heats up
Wed, 09/12/2018 - 12:00
The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these…
MDSAP’s Final Pilot Report: A Glass 10% FullThe program attempts to ensure absolute confidence in medical-device certification, but at too great a cost
Wed, 11/22/2017 - 12:03
I have written previously about the Medical Device Single Audit Program (MDSAP) created by the International Medical Device Regulators Forum (IMDRF). MDSAP is viewed as a single audit covering the United States, Canada, Brazil, Australia, and Japan…