The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are...
The updated version of ISO 14971, Application of Risk Management to Medical Devices, has officially been published this month; this is an update to the previous versions, ISO 14971:2007 and EN ISO 14971:2012. The major changes include reorganization of the...
The up-classification of devices under the new EU MDR has definitely put some manufacturers in a very difficult situation. This is true especially for manufacturers of class I devices that have now been up-classified under the new EU MDR. Under the...
ISO 13485:2016 emphasizes a risk-based approach to the entire QMS, shifting from the traditional risk approach which is highly product design-focused. ISO 14971-Risk Management for Medical Devices is the gold standard when it comes to applying a risk-based approach to...
For manufacturers of medical devices, it can be an easy trap to fall into only focusing on the compliance of your device and forgetting your supply chain. The FDA has strict regulations around Purchase Controls (supplier management) that are outlined...
The new European Medical Device Regulations and the In Vitro Diagnostic Devices regulation have a lot emphasis on the post-market activities that a manufacturer must undertake. With the clock ticking fast to meet the deadline for the transition period, which...
One of the major changes with the EU MDR that medical device manufacturers will feel as they transition to comply with the new regulation is the change in requirements for device classification. As medical device classifications change so do the...
Companies are often in doubt about outsourcing Internal Audits especially when they have an in-house quality assurance department. For small and medium-size companies, it might be a burden on their financial resources, however it is the right approach toward compliance. According...
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states that every class III and class II medical device manufacturer “shall establish and maintain procedures to control the design of...
Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer complaints to be handled by a designated customer handling unit and if you are a small company this might seem a little...