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ISO 13485

ISO 13485 is an international management standard developed specifically for medical device manufacturers. It provides a harmonized model for creating and maintaining an effective quality management system (QMS) for the design and manufacture of medical devices. In 2016, ISO 13485 was revised to address suppliers and incorporate risk. ISO 13485:2016 explicitly requires device makers to apply a risk-based approach to all quality processes, including outsourced processes, as well as more structure to validation, verification and design transfer. ISO 13485:2003-certified companies have three years to transition to ISO 13485:2016.


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Educational Materials

Get insider information about the most relevant issues in ISO 13485 today, and how to navigate and overcome the complexities of FDA and ISO compliance.

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  • This white paper provides a concise overview of ISO 13485 and examines how obtaining certification to the standard can open doors to untapped domestic and international business opportunities. It also explains how to avoid becoming one of the 50 percent of device companies that fail to obtain recertification due to inadequate manual processes.
  • Since the majority of medical device manufacturers must comply with both 21 CFR 820 QSR and ISO 13485 standards, it is practical to consider establishing an integrated 21 CFR 820 and ISO 13485 quality management system (QMS). This white paper delineates the intersection points of these regulatory requirements and provides valuable information about document naming and numbering strategies for enhanced compliance.
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ウェブセミナー
  • This webinar is Part 2 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.
  • This webinar is Part 3 of the ISO 13485:2016 webinar series. It addresses the universal changes in this regulation and how to implement them.

Educational Materials

E-Book
  • Since 2000, we have benefited from a technology-driven era in regulatory compliance. This e-book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.

Product Information

Discover how MasterControl ISO 13485 can manage your quality process, all while mitigating risk, improving speed-to-market, and generating ROI.

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Q&A's
  • What do you need to know about compliance with 21 CFR 820 and ISO 13485? This informative question and answer summary explains what these standards are, who they cover, their relationship to each other, and much more.

Demos & Toolkits

Get in-depth, comprehensive resources to guide development of your ISO 13485 program.

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Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
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Toolkits


How MasterControl Helps Device Makers Meet the Latest Requirements of ISO 13485


The MasterControl quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate adherence to the latest ISO 13485 standard. Here's how MasterControl can help meet key requirements and at the same time increase efficiency and keep compliance costs down:

ISO 13485 Requirements

MasterControl Features to Ensure Compliance with ISO 13485


(ISO 13485 -- Clause 4)

医療機器のための品質管理システムを構築すること。製造業者は、文書化され、管理され、効果的に実施され、維持されるISO 13485に準拠した品質手順を用意すること。


MasterControl Documents™ helps medical device companies comply with ISO 13485 by automating routing, escalation, approval, and delivery of standard operating procedures SOPs, policies, and other documentation. MasterControl provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports which ultimately helps in meeting these standards.


Requires written supplier agreements and risk-based control of outsourced products.

With MasterControl Supplier™, all supplier management statuses and quality information is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.

MasterControl Risk™ provides employees from different departments with a simple and efficient method for participating in risk assessment and mitigation activities. MasterControl's risk management software offers electronic workflows and signatures for execution, review, and approval of risk activities and documentation. Personnel can leverage a risk-based approach in multiple processes including supplier qualification activities.


(ISO 13485 -- Clause 6)

製造業者は、従業員の適切な経験や教育、トレーニング、技術を確認すること。必要な能力を明確にすること。トレーニングの必要性を構築し評価すること。能力の記録は維持すること。

Effectiveness of training must be commensurate with risk.

MasterControl Training™では、トレーニング業務の割り当てやモニタリング、オンライン試験のグレーディングの自動化により、医療機器会社によるISO 13485への準拠をサポートします。トレーニングコースの順番付けが可能で、必要条件のコースが完了すると次のコースが自動的に開始されます。グループサインオフ機能を搭載しているため、規模の大きな担当者グループのトレーニングの検証にも対応可能です。

MasterControl's risk analysis software solutions include triggers to perform a risk analysis. This enables a methodology that establishes objective risk metrics. These can then be used as thresholds for decision-making.


(ISO 13485 -- Clause 8)

製造業者は、適合性を実証するため使用する救済プロセスを計画すること。適合性を実証するために救済プロセスを使用すること。不適合品の手順を構築すること。不適合は是正し、文書化すること。

MasterControl CAPA™ helps medical device manufacturers comply with 13485 by integrating the corrective and preventive action process with other quality processes. The software provides best-practice "8D" process that guides the quality team through every step of CAPA. A CAPA form can be launched directly from another form (i.e., a nonconformance report). Automatically enters relevant data into a CAPA form, reducing data entry and eliminating errors from manual transfer of information. Provides customizable reporting capabilities to help managers monitor entire quality management life cycle.


(ISO 13485 -- Clause 8)

製造業者は、定期的に内部監査を計画および実行すること。

MasterControl Audit™ は、監査プロセスの自動化や合理化、効果的な管理によって、医療機器製造業者がISO 13485に準拠するのをサポートします。この監査ソフトウェアは、スケジューリングから計画の実施、完了までの高度なトラッキング機能を備えています。 基本的な監査情報及び監査結果をトラッキングするベストプラクティスフォームを提供します。繰り返し行われる全ての監査関連活動のスケジューリングを自動化し、分析とレポート作成機能を提供して管理の視認性を向上させます。


(ISO 13485 -- Clause 8)

製造業者は、顧客からのフィードバックを集める手順、及び表面化した問題をモニタリングするためのフィードバックシステムを構築する必要があります。

MasterControl Customer Complaints™ helps medical device manufacturers comply by streamlining the complaint-handling process and reduces the lifecycle from submission to resolution. A simple, three-step process is incorporated in a pre-configured, multi-page form that starts with processing of a complaint, moving to internal investigation, and culminating with issue resolution.


(ISO 13485 -- Clause 5)

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.

MasterControl Nonconformance™ は、不適合材料やコンポーネント、パーツ、完成品の同定や評価、レビュー、処理に関するプロセスを自動化、管理、合理化することにより、医療機器製造業者によるISO 13485への準拠をサポートするように設計された強固なソリューションです。 ソリューションのベストプラクティスフォーム及び5段階プロセスにより、責任担当者全員を連携させ、不適合品の効果的かつタイムリーな処理を実現します。

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