What has been included in the new ISO 13485:2016?

What has been included in the new ISO 13485:2016?

This is a guest post by Dr. Michael Rinck, founder and managing director of MT Promedt Consulting.

 

The International Organisation for Standardisation (ISO) released its long-awaited revision to the ISO 13485. This global standard for medical device quality management systems (QMS), is replacing the previous ISO 13485:2003. 

Why You Can’t Ignore Usability Engineering

Why You Can’t Ignore Usability Engineering

A product should work well for its user with as minimal guidance as possible. People do not wish to spend much of their time trying to figure out how to use the product or worse, use a product that do not really serve its purpose. This is why usability engineering is becoming more important over the years and definitely playing a big role now in the medical device industry.

Increase Productivity? Think Document Control.

Increase Productivity? Think Document Control.

As your company grows, the amount of documents your team creates and manages increase. This is great news and it means that your company is growing! However, that also does not mean productivity must go downhill. Thus, it is important to have a process in place to manage them in a systematic and optimised manner. We call this ‘Document Control’.

What is a Regulatory Strategy?

What is a Regulatory Strategy?

The pathway from design to commercialisation for a new medical device can be complex and full of uncertainty. A specific product claim or intended use can lead to varying product classification and registration path due to differences in laws and regulations of different markets. A regulatory strategy will help you to bring into consideration the various regulatory issues and put together a plan that will bring your medical devices into the target markets.

5 reasons why you should adopt an eQMS for your business

5 reasons why you should adopt an eQMS for your business

Medical device design & development (D&D) processes have never been easy to establish. Organisations have been searching for ‘templates’ or ‘ideal’ procedures to manage multiple projects, hoping to achieve a consistent output. Till current, more than 50% of companies still uses general document software to manage their medical device D&D. Such method is often insufficient to handle medical device development. The good news is there are electronic quality management system (eQMS) software in the market specially designed for medical device companies.

What is a Quality Management System?

What is a Quality Management System?

This is still a big question mark for most people. We are often focused at building a good product and/or service, managing project timeline, keeping investors excited or engaging potential customers. Many items down the checklist. Of course, these are important milestones for the survival of all businesses. However, setting up a set of internal procedures or system is never less important. This structure must be put in place at some point of time – with the objective to ensure your eventual product/service consistently meet expectations of customers and regulators (in regulated industry like medical devices). This is widely known as the Quality Management System (QMS) of a company. 

Step-By-Step Guide to Classification of General Medical Devices

Step-By-Step Guide to Classification of General Medical Devices

In some countries, product classification principles are standardised across both IVDs and general medical devices but not for some. One good example is the U.S. FDA. 

How about those countries, which have product classification routes designed differently for the two main categories of medical devices such as Singapore?Today, we shall discuss about the classification of a general medical device!

Step by Step Guide to Classification of IVDs

Step by Step Guide to Classification of IVDs

What we are about to share with you is a guide to medical device regulatory classification.

In this guide, we will provide you the step-by-step approach to how your in vitro diagnostic medical device (IVD) will be classified in the United States and Singapore.