Quality Management

Maintaining desired safety and efficacy of medical devices is only possible by implementing systematic and comprehensive set of processes, procedures (SOP, WI) and activities in Medical Devices.  Working according to Good Manufacturing Practices (GMP) for the people, products, processes, procedures and premises and following the Good Documentation Practices (GDP) is not always easy when there is operational pressure on the organisation. This requires a strong quality awareness and a regular follow-up of the system. As PMforMedTech, we do embed quality in every step we take. Whether you need to establish these set of processes and procedures from scratch or you want to improve your overall process quality, we can help you.  

Both ISO13485 and 21 CFR 820 suggests that medical device companies should build a Quality Management System (QMS) in their organisation. This is critical to be able to support the business leadership, promote customer focus and improve company culture. It helps the organisation to manage new innovations and to understand any issues arising during operation. Quality Management system is not only about quality but also about management. 

This is how we approach to QMS's at PMforMedTech and this is how we build our systems. 

When we talk about quality control processes, we tend to think about "Cost of Quality" in the meanwhile. How do we establish a good quality control process? Do we know about our Critical Quality Attributes (CQA)? Do we understand our Critical Process Parameters (CPP) and Critical Control Points (CCP) in our process?  Do we have enough control mechanisms or is it really an overkill? 

Let's understand all these questions together!

We believe all Corrective and Preventive Actions (CAPA) in an organisation are mini projects.  The main focus of CAPAs are to have a better functioning organisation every coming day. This is only possible by giving the desired attention to not only to corrective actions but also to preventive actions. We can work together to plan and manage your CAPA's accordingly and to carry your organisation into a better version of itself. 

In 2017 when the new MDR (EU MDR 2017/745) and IVDR (EU IVDR 2017/746 are published by European Union most of the medical device companies were aware of the level of disruption that these new regulations would bring to the industry. After several years of effort and spending billions of euros,  the transition is still not complete and companies still do need guidance on the new regulations. Such complex transitions need a project management mentality with a disciplined approach. We can work with your company to provide this disciplined approach for your remediation activities when there is need to upgrade to new regulations and standards.