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Medical Device Consulting 

 Consulting Saves Time & Money

Partner with a highly-experienced, focused, flexible group of experts who will help see your medical device project through to completion the right way.  EU MDR Compliance, including DHF, Legacy File Remediation, Labeling Specialist, Trace Matrix, BSI Checklist / Dekra & MDR Readiness.

Are you looking to get your medical device project back on track? TSG is here to give you the advice and support you need at the right time.

 Questions to ask yourself about your specific project include:

Is your project on budget and on time?

TSG work with medical device companies at any stage in their development lifecycle to ensure efficiency and bring your device to market.

Do you have a technical problem that is delaying your project?

With our familiarity of FDA regulations, TSG helps relieve excessive regulatory burden by targeting specific aspects as valued by the industry. 

We have the experience and skills needed to quickly resolve your project development roadblocks.

Is your project delayed due to staffing level or skills?

TSG has on staff and the resources to take on any project you need assistance on. Check out our Company Overview page to learn more about our company.

Do you lack transparency?

Our Engineers / PM keep a constant level of communication not only with each other but with their clients  to create a stress-free transparent environment.

Is your project being managed correctly?

We employ agile project management by breaking down the project into incremental steps, and then thoroughly reviewing each step. 

This allows us to efficiently make changes and receive company feedback. 

Do you have the right tools?

TSG is equipped with different methods of medical device Tool Validation which gives our team the opportunity to see which methods fit best for you and your device.

Do you have the right experience?

With over a proven resume in the medical device industry we have the experience to help ensure the success of your project.

Risk Assessment 

GAP Analysis 


FMEA Consulting 

EU MDR/QMS Compliance Review & Development 

EU MDR, 21 CFR 820, ISO 13485, ISO 60601, IEC 62304, Part 11 HIPAA Compliance Review

FDA, ISO and CE Compliance Consulting

Consult with experienced professionals

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