We are an Industry Authority

A Different Approach

At MCGetz Consulting, we are seen as a valued partner within the Medical Device and Pharmaceutical industries, that collaborates with our customers to understand their quality and compliance needs; help create and execute their compliance strategies while balancing their business demands.

At MCGetz Consulting, we don’t ASK for testimonials – we wait for them to develop organically  through face to face conversations, commentary or  posts.

 

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Project Planning with a Quality Consultant

 

We treat all our clients as individuals and don’t think a one-sized-fits-all solution will work. We’ll help you develop a customized plan to meet your specific needs.

Quality Over Quantity

If you’ve envisioned your quality processes working for you, let MCGetz Consulting show you the way. Using a proven methodology, we can develop a quality and compliance strategy that is commensurate with product risk and aligns with your business goals.  We are not going to sell you what you don’t need; our goal is to listen and drive for results.
Change can be daunting especially when establishing any quality process i.e. design control.  We respect the unique personalities, culture and market that has grown your business and will partner with you to guide you through the Change Management process.  Our experience is that success of any Quality Management System implementation starts with Senior Leadership.  We will work with those who are skeptical or resistant, listening to their concerns and getting alignment so that integration becomes everyone’s goal and all own the results.

Services

Contact Lense is a medical device

Medical Device – Quality System Management

Whether a start up or established Medical Device company, we can develop  a Quality System to meet your compliance and business goals.

in vitro diagnostic medical device

In vitro Diagnostics (IVD) Lab Developed Tests (LDT)

IVD vs LDT; We can provide insights on developing a regulatory and quality strategy.

Pharmaceutical & Medical Device combinations

Combination Products

We can provide a roadmap to navigate through the world of Part 4 requirements, based on real-life experience.

 

Managing Quality Compliance thru Training & Auditing

Training & Auditing

Know that you are compliant on the changing regulations with training curricula and audits that assess the status of your QMS.