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ISO 13485 Blog

Verlene Law

How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018

Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in terms of quality, safety, and efficacy. The ISO 13485 standard defines the different areas in …

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Verlene Law

How to comply with the latest changes in ISO 13485 clause 7.2.3 Communication

Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as relying on verbal agreements and failing to document changes, could lead to high costs in terms of operational losses. A 2016 survey by the Society for Human Management (SHRM) asked …

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Verlene Law

How can ISO 13485 clause 7.4, Purchasing, enhance procurement?

We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase, the cost of the product, the quality of the product, and previous purchasing experience. This workflow is not always as smooth as we want it to be. Could it be …

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Verlene Law

Common mistakes with ISO 13485:2016 documentation control and how to avoid them

Documentation control is the first task that most people would prepare for before an upcoming audit. Prior to an audit, we would ensure that any changes made to the work procedures are updated, review the Quality Manual and Quality Management System documents, and ensure that each process owner is aware …

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Strahinja Stojanovic

Production and service provision process in ISO 13485

Clause 7.5 of ISO 13485, which deals with requirements for production and service provision, causes a lot of confusion. The main reason for this is the fact that the standard aims to define requirements applicable to a wide variety of manufacturing and service provision processes in the medical device industry. …

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Strahinja Stojanovic

How to define roles and responsibilities within an ISO 13485-based QMS

When you are developing a Quality Management System (QMS) it is necessary to assign and document the roles and responsibilities of your management system. ISO 13485 highlights this as shown primarily in the requirements of clause 5.5.1 and 5.5.2. So, what roles and responsibilities do you need to identify and …

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Strahinja Stojanovic

How to perform management review according to ISO 13485

Many companies see Management Review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this is far from the truth. Regardless of how you organize your management review, either through routinely scheduled meetings or a more continuous review process, the act of reviewing the available …

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Strahinja Stojanovic

What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?

Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what can be a volatile economy. However, financial success is of little consequence if the government compels you to dissolve your company for failing to comply with legal requirements, or if …

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Waqas Imam

How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK

In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a vessel or any other controlled testing location. In vitro diagnostic medical devices (IVD’s) comprise of chemical reagents, appliances, and systems anticipated for analysis and diagnosing a disease or any other …

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Waqas Imam

Medicines and Healthcare products Regulatory Agency in the UK – What does it do and how can ISO 13485 help?

The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s governmental agency that controls and regulates blood components for transfusions, advanced therapy medical products, medicines and medical devices throughout the United Kingdom. MHRA is an agency that works under the UK Department of Health. Within its organization, the …

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Waqas Imam

How to use ISO 13485 to get your devices approved for CE Marking

The CE marking is a gateway to marketing products in Europe, even if the medical device was produced somewhere other than the European Union. It is the producer’s mandatory obligation to acquire and display the CE mark on the device before marketing it in the European Economic Area (EEA). If …

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Waqas Imam

Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. One of the main reasons that ISO 13485 has been revised is the …

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Waqas Imam

Considering human factors in Medical Device Design

Human factors are one of the most important considerations in the design of medical devices, and are reflected in an ISO 13485 Quality Management System as design and development inputs. Human factors to consider include the requirements of device users, the environment where the device is being used, and the interface of …

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Waqas Imam

How to use ISO 14971 to manage risks for medical devices

A patient undergoing a surgical procedure places his trust in the surgeon, the institution, and the procedure of surgery. He is least concerned about the medical devices, and not aware of the associated safety risks. Therefore, the patient accepts the risks of a medical device without any knowledge or awareness. …

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Waqas Imam

How to use ISO 13485 to fulfill FDA regulatory classes for medical devices

As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in ISO 13485, with the latest version putting additional emphasis on this factor. The Food and …

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