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QMS Compliance

14971 risk management webinar
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets. Manufacturers around the world are recertifying to the new standard, which emphasizes risk management as a key component of quality management systems. EN ISO 14971:2012 defines risk management processes for medical device manufacturers. But, implementing ISO 14971 can be intimidating. In this webinar, Dr. Dieter Dannhorn breaks down the requirements of ISO 14971 compliance and explains how to strategically implement the standard into your quality...
Biocompatibility testing: an intimidating, time-consuming, and, at times, very expensive requirement in most major medical device markets. Biocompatibility testing is the systematic evaluation of a product's biological safety to avoid any risk of bio-incompatibility with the human body. If you are marketing a device in Europe, the US, or even beyond, the ISO 10993 series is your guide to biocompatibility testing requirements. It provides guidelines and requirements for manufacturers to appropriately mitigate the biological risks up to and including testing to confirm biocompatibility. In this...
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how the new standard will affect your company: do I have to completely overhaul my QMS? When do I have to comply? ISO 13485:2016 provides an international standard that can be truly harmonized across multiple regions and regulatory requirements. But it also introduces notable QMS changes, particularly in the area of risk management. In this 16-page white paper, we answer your biggest questions about ISO 13485:2016, including: Overview of the update to...
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The changing legislative landscape combined with the limited resources at the Brazilian Health Surveillance Agency (ANVISA) often cause frustration for domestic and foreign manufacturers. But if you are willing to put in the effort, the Brazilian market has potential. In this 9-page white paper, we'll answer your biggest questions about regulatory requirements for medical device manufacturers in Brazil, including: What is Brazilian medical device/IVD GMP?...
What are the most common inspectional observations that warrant an FDA Warning Letter citation (Form 483)? Believe it or not, Purchasing Controls is among the top three. Whether you have an audit coming or you’re implementing the Quality System Regulation (QSR), pay special attention to Purchasing Controls. This white paper addresses one of the biggest vulnerabilities for medical device companies selling in the US. Take a deep dive into compliance with 21 CFR Part 820.50 - Purchasing Controls. What you will learn in this 7-page white paper: What are the challenges associated with purchasing...
Der deutsche Text ist eine Übersetzung aus dem englischen Original und kein offizieller Gesetzestext. Bitte verwenden Sie als Referenz immer den englischen Originaltext. Ansprüche aus Fehlern in der Übersetzung können nicht geltend gemacht werden. Deutsche Übersetzung durch Emergo Deutschland GMBH. [Ausgabe vim 1. April 2010] Title 21 - Food and Drugs Chapter I - Food and Drug Administration Department of Health and Human Services (HHS) Subchapter H - Medical Devices Part 820 QUALITY SYSTEM REGULATION (QSR) Teil A – Allgemeine Vorschriften § 820.1 - Geltungsbereich § 820.3 - Definitionen §...
Learn about Health Canada
The following Registrars are authorized by Health Canada to issue quality management system certificates for: CAN /CSA ISO 13485:2003 ISO 13485:2003 Registrar Web site BSI America, Inc https://www.bsigroup.com/en-US/ DEKRA Certification B.V. http://www.dekra-certification.com/en/home DQS Medizinprodukte GmbH http://www.dqs-medizinprodukte.de/en Intertek Testing Services North America Ltd. (ITS) http://www.intertek.com/business-assurance/ Laboratoire national de metrologie et d’essais, division certification G-MED http://www.gmed.fr Lloyd’s Register Quality Assurance Inc. (LRQA Inc.) http://...