A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. A Clinical Evaluation is required for all medical devices to be marketed in Europe. Alternative treatment options including no treatment should be […]
Author: Annette Schaps
How many procedures are too many or too few?
When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy certification requirements? It seems that there is a perception that if the number is too big, then the quality system will be too burdensome. If the number is too small, then […]
MDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional Provisions
If you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Currently, the MDD is no longer but if you have products that are CE marked under the MDD, Article 120 of the MDR may allow you to […]
Quality System Process Changes
Continuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a predefined process. Perhaps your company has a software development process that it has been using for some time. Someone at your company thinks that the process is too burdensome and would like “streamline” […]
Quality System Processes
A Quality Management System (QMS) is a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. ISO 9001:2015 defined approach to QMS is the most commonly used. However, not all processes defined by ISO 9001:2015 may be pertinent to your organization. So, the question is: What are the processes needed for […]
Which Standard should I use?
The prefix of the standard provides clues as to which country it originates from. For example, ASTM stands for American Society for Testing and Materials and ANSI stands for American National Standards Institute. ASTM and ANSI are typically used in the United States. ISO, which stands for International Standard Organization, defines many standards which are […]
What is ISO 13485?
Although the ISO 9001 Quality System standard can be used by any industry, ISO 13485 is the go-to Quality System standard widely used (and recognized) in the medical device industry. ISO 13485 aims to facilitate global alignment between other medical device regulations such as the United States FDA’s Quality Management System Requirement 21 CFR 820. ISO […]
The importance of documenting processes
Super employee Mitch has left the company! Will we ever be able to find someone to replace him? Probably not immediately. But if his work processes were well documented, someone could be trained to step into Mitch’s role and take over where he left off. Documenting and detailing one’s daily tasks takes time and may […]
Risk Management
The topic of Risk Management often seems overwhelming. The reason for identifying risks is so that you can mitigate them and prevent bad things from happening. Consider breaking down risks into different buckets. I categorize risk into three areas: Business, Product, and Compliance risks. What are some of your business risks? Not securing funding? Lawsuits […]
Quality Management System: Employee Roles
If you are creating or in an organization, the question of what “role” each employee plays will come up. Naturally, we think of assigned titles such as “President”, “CEO”, “Founder”, “CTO” as a person’s assigned role. But do people with these assigned titles truly understand what their responsibilities in their role really means? In a […]