The PMS system must be documented and implemented within the manufacturers’ QMS. The PMS should be risk-based according to the products manufactured. The PMS system must be suitable to gather, record and analyse the relevant data. It should be done in accordance with the control strategy of the manufactured product to gather relevant data regarding […]
Below you will find a general process for MDR Compliance. There are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (SPR). Also, the provisions […]
All medical devices, whether currently certified to a European Medical Directive or yet to be certified, will need to comply with the requirements of the MDR to be certified under the MDR. The MDR requires manufacturers to demonstrate an effective QMS. Therefore, to receive certification to the MDR, you must have a compliant QMS. […]
If GDPR applies to your business, it’s worth working to make your systems GDPR compliant. You should consult with your business’s legal team on what exactly compliance means to them, but here are some key considerations: Establish the legal basis for collecting personal data. In most cases, it will be that you have obtained that […]
If GDPR applies to your business, it’s worthwhile to know a few of the key objectives of the regulation. First, providing individuals with greater control over how their personal data is used is the heart of the GDPR. A major part of compliance is shifting from operating on the assumption that you can use customers’ […]
GDPR is fairly broad in terms of the businesses that it regulates. It applies to two broad strata of companies: (a) those that are “established” in the European Union and (b) those that process data of European Union residents. If your business has a branch in the European Union, seeks to do business with any […]
European Union’s General Data Protection Regulation (GDPR) In the 18 months since the European Union’s General Data Protection Regulation (GDPR) has gone into effect, more than $126M in fines have been levied against companies who haven’t complied with the law, including significant fines for Google, British Airways, and Marriott, and all signs point to continued, and possibly even […]
In the development process, assessing risk is a “best-guess” e ffort. Once you’ve launched your product, you now have confirmation that you’ve captured the appropriate risks and acceptability, since feedback and complaints are captured in the same single system that handles risk management. Fully understand everything that is impacted by a complaint. If there is a […]
Feedback in any form is a good thing. Most companies don’t have the mechanisms in place to collect feedback today so it gets lost, and hinders you from optimizing that feedback in a full product lifecycle. There is good stuff coming from your customers. Listen to it and do something about it. Their design suggestions, […]
Regulators are becoming much more focused on post-market surveillance and risk management in the medical device industry. Whether you’re seeking regulatory compliance in the United States or European market, standards are quickly harmonizing and it’s important to establish a compliant PMS system to ensure that you can sell your device around the world. On top […]