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ISO 13485 Compliance

Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of ISO 13485 compliance is to ensure the quality, safety and effectiveness of medical devices. The ISO 13485 standard is a series of requirements that help device makers develop a quality management system. According to ISO, these requirements "can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services." The publication of the 2016 version of ISO 13485 allows manufacturers that currently meet the requirements of ISO 13485 compliance three years to transition from ISO 13485:2003 to ISO 13485:2016.


Watch Videos: Learn More About ISO 13485 Compliance

Kostenlose Ressourcen zu ISO 13485 herunterladen

Educational Materials

Holen Sie sich heute noch Insiderinformationen zu den relevantesten Themen in Bezug auf ISO 13485, und erfahren Sie, wie Sie die Komplexitäten der FDA- und ISO-Compliance umgehen und bewältigen.

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White Paper
  • Dieses Whitepaper gibt einen knappen Überblick über ISO 13485 und untersucht, wie die Erlangung einer Zertifizierung nach diesem Standard den Weg für bisher ungenutzte geschäftliche Möglichkeiten im In- und Ausland ebenen kann. Zudem wird erläutert, wie ein Unternehmen vermeiden kann, einer der 50 Gerätehersteller zu werden, die aufgrund mangelhafter manueller Prozesse keine erneute Zertifizierung erlangen.
  • Da die meisten Medizingerätehersteller sowohl die Norm 21 CFR 820 QSR als auch ISO 13485 beachten müssen, ist es sinnvoll, die Einrichtung eines integrierten Qualitätsmanagementsystems (QMS) für 21 CFR 820 und ISO 13485 in Betracht zu ziehen. In diesem Whitepaper werden die Schnittpunkte dieser regulatorischen Anforderungen erläutert. Zudem enthält es wertvolle Informationen über Dokument-Benennungs- und Nummerierungsstrategien für eine bessere Compliance.
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Webinare
  • Dieses Webinar ist Teil 2 der Serie von ISO 13485:2016-Webinaren. Es behandelt die universellen Änderungen dieser Vorschrift und bietet Informationen dazu, wie diese implementiert werden.
  • Dieses Webinar ist Teil 3 der Serie von ISO 13485:2016-Webinaren. Es behandelt die universellen Änderungen dieser Vorschrift und bietet Informationen dazu, wie diese implementiert werden.

Educational Materials

E-Book
  • Seit dem Jahr 2000 profitieren wir in Bezug auf regulatorische Compliance von unserem technologiegetriebenen Zeitalter. Dieses E-Book führt 16 Gesetze und Initiativen auf, die die Modernisierung mit vorangetrieben haben. Es ergründet, wie sowohl Aufsicht unterliegende Unternehmen als auch Regulierungsbehörden im vergangenen Jahrzehnt durch die Nutzung von Technologie Compliance vereinfachen und damit verbundene Kosten senken konnten.

Produktinformationen

Erfahren Sie, wie Sie mit MasterControl ISO 13485 Ihren Qualitätsprozess verwalten und gleichzeitig Risiken mindern, die Markteinführung beschleunigen und Ihren ROI verbessern können.

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Fragen und Antworten
  • Was müssen Sie über Compliance mit 21 CFR 820 und ISO 13485 wissen? In dieser informativen Zusammenfassung mit Fragen und Antworten wird erklärt, was diese Normen beinhalten, für wen sie gelten, wie sie miteinander verknüpft sind und vieles mehr.

Demos & Toolkits

Holen Sie sich detaillierte, umfassende Ressourcen, die Sie bei der Entwicklung Ihres ISO 13485-Programms unterstützen.

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Interaktive und Live-Demonstrationen
  • Das Qualitätsmanagementsystem (QMS) von MasterControl bietet eine breite Palette an Softwarelösungen für Qualitätsmanagement, Dokumentenlenkung, Produktlebenszyklusmanagement, Lieferantenmanagement, Auditmanagement, Schulungsmanagement und weitere, auf Ihre Unternehmensbedürfnisse abgestimmten Lösungen. Dieser Überblick zeigt, wie Sie mit dem QMS von MasterControl Abfall vermeiden, Audits vereinfachen und die Einhaltung behördlicher Vorschriften erleichtern.
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Toolkits


Why ISO 13485 Compliance is Important in the US


Although ISO 13485 compliance is voluntary in the United States, it provides a framework for meeting medical device quality requirements in international markets. ISO 13485 compliance also helps meet the requirements outlined in the FDA's 21 CFR Part 820 for the Quality System Regulations (also known as QSR and cGMP), which is applicable to medical device manufacturers and importers. In the U.S., compliance to FDA QSR is required. Any U.S.-based company that wishes to market its medical device products globally must comply with both 21 CFR Part 820 and ISO 13485.


Why ISO 13485 Compliance is Important in Europe


While ISO 13485 compliance is also voluntary in Europe, it outlines the requirements for a comprehensive management system for the design and manufacture of medical devices. Complying with ISO 13485 is often seen as the first step in complying with European regulatory requirements. ISO conformance is important because the conformity of medical devices and in vitro diagnostic medical devices according to EEC Decrees 93/42/EEC, 90/385/EED and 98/79/EEC must be assessed before the sale of the medical device is allowed. ISO 13485 certification allows devices makers to meet the aforementioned EEC Decrees with less difficulty, which expedites market entry.

The preferred method to prove ISO 13485 compliance is the certification of the Quality Management System according to ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body. A positive assessment is necessary for the authorization of the CE-identification and the permission to sell the medical device in the European Union.


Why ISO 13485 Compliance is Important in Canada and Japan


Unlike Europe and the U.S., ISO 13485 compliance is compulsory in both Canada and Japan. Conformance to ISO 13485 is necessary in order to secure a Canadian Medical Device License for Canadian class II, III or IV medical device. Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinance #169 is based on ISO 13485, and it is required in Japan.

Even in countries where ISO 13485 compliance is not mandatory, it is expected by investors, partners and customers. A 2011 survey of 900 ISO 13485-certified medical device manufacturers showed that 28% of respondents had become certified not because it was required by law but because it was required by their customers. Third-party certification to ISO 13485, as well as other ISO medical device standards, assures customers, prospective customers, suppliers and foreign trade officials that a company's operations are safe and effective. What's more, the marketing and business advantages of ISO 13485 compliance are substantial.


Business and Operational Benefits of ISO 13485 Compliance


There are many benefits a medical device company may gain from ISO 13485 compliance, including:

  • Marketing and promotional benefits: Companies deemed ISO 13485 compliant receive a certificate which can be displayed on corporate advertising and marketing materials, leading to increased credibility with customers, employees and stakeholders. Increased credibility ultimately leads to increased brand equity, a desirable competitive advantage.
  • Communication and operational benefits: Like all ISO medical device standards, ISO 13485 compliance promotes harmonization, e.g., a standardized quality vocabulary. When device makers are using the same language to communicate, there is less chance of miscommunication and misunderstandings that can lead to deviations and other quality events than cause patient harm and regulatory sanctions.
  • Financial benefits: When company processes correspond to the ISO 13485 standard, it means they are transparent. Transparency saves money. Unclear or vague documentation, which is often what keeps company processes and ISO 13485 compliance at odds, is avoided.


Using Automation to Optimize ISO 13485 Compliance and Maintain Certification


According to Quality Digest, many companies striving to achieve ISO 13485 compliance continue to prepare for or maintain ISO registration using manual processes, which are time consuming and prone to error. Manual registrations are also expensive; they cost more than $100,000, and, on average, take up to 12 months to prepare. Moreover, many companies, as much as 50 percent, will fail to recertify because they were not able to maintain and scale their manual processes.

When you imagine the amount of time it takes to key in or type the required quality documents, locate paperwork and manually compare the data to the information provided in the application, it's easy to see the disadvantages of attempting ISO certification in a manual environment. Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring ISO 13485 compliance and maintaining certification.

For More Information About ISO 13485 Compliance


To learn more about ISO 13485 Compliance, or about any other ISO standard (e.g., ISO 9001, ISO 9001 2000, ISO 9000 2000, ISO 14000, ISO 14971, etc.), please feel free to contact a MasterControl representative

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