Lost in the maze?

Logical processes and well-written procedures are the cornerstone to an effective Quality Management System (QMS).  Everything has a process and  when its clearly defined and easily understood, employees become champions of compliance. 

Quality System  Assessments and Audits can help us help you to seek out areas of concern and improvement.  Let us bring our professional auditing expertise to work for you!     We have more than 20 years professional QMS auditing across multiple standards and regulations.  

• ISO 13485: 2016 
• ISO 9001: 2015 
• US FDA 21 CFR 
• MDSAP (Medical Device Single Audit Program for US, Australia, Brazil, Canada, Japan)
• EU MDR (European Union Medical Device Regulations) 

Are you considering certification for your Quality Management System to ISO 13485?  Are your customers requiring it? We can help guide you through the steps to prepare and develop your Quality Management System and your employees for what to expect and how to succeed. 

The Medical Device market has become an international community and our supply chains reach across all corners of the globe.  It is vital that Medical Device companies have well developed supplier management processes including new supplier approval, ongoing supplier monitoring (assessment/ audits), and strong supplier corrective action programs.  As more of the quality of our products is defined by the actions fo our suppliers, or oversight of those suppliers must become more stringent and well documented.  Let us help you set up meaningful and realistic supplier management programs.  

We all want our manufacturing process to flow smoothly, our suppliers to provide products and materials -on time,-without flaws; and our  logistics and transportation providers to move our products quickly and without damage.  However, planning for  those unwanted events that may lead  to customer complaints, corrective actions, regulatory reports, or even recalls and field actions is a necessity.  If those  welcome events occur,  a well defined  and predictable process and communication flow will be  vital.  Let us help you plan for the unexpected and ensure a smooth response. 

There is a very real cost to doing business in the Medical Device community.  Each product, each jurisdiction, and each agency has their own set of requirements and fees.  Let us help you plan and execute a regulatory strategy to maximize opportunity and minimize costs iin both time and currency.