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Tom Rish

Tom Rish
Tom Rish is a Medical Device Guru at Greenlight Guru who works with customers to utilize their QMS software to build safer products on expedited timelines. He is a Biomedical Engineer who began his career developing implant and instrument systems in the orthopedic industry. He enjoys helping customers successfully navigate regulations across global markets as they bring life changing technologies to market.

Author's Posts

3 Medical Device Security Challenges (and Solutions) - Featured Image

3 Medical Device Security Challenges (and Solutions)

Technological innovations in and around the medical device industry have made it possible for compan...
Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know - Featured Image

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

Your device history record (DHR) is one of the final forms of documentation you’ll need before your ...
Ultimate List of ISO Standards for Medical Devices - Featured Image

Ultimate List of ISO Standards for Medical Devices

The International Standardization Organization (ISO) is an independent, non-governmental organizatio...
Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry - Featured Image

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

To ensure quality and mitigate the risk of subjectivity or bias, the European and Canadian medical d...
What is a Class 2 Medical Device in the US? - Featured Image

What is a Class 2 Medical Device in the US?

The goal of anyone involved in medical devices is simple: produce high quality products that improve...
Medical Device 3D Printing: Should You Make the Move? - Featured Image

Medical Device 3D Printing: Should You Make the Move?

The medical device industry has grown immensely over the past several decades. But with new technolo...
What is a Class 1 Medical Device? - Featured Image

What is a Class 1 Medical Device?

In the US, the governing body tasked with regulating the medical device market is the Food and Drug ...
3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US - Featured Image

3 Medical Device Reimbursement Strategies to Recoup Your Investment in the US

Anyone who works in the medical device industry will tell you that quality and patient care is of th...
Understanding the Premarket Approval (PMA) Process - Featured Image

Understanding the Premarket Approval (PMA) Process

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

Clinical investigations play an important role in your journey of bringing a medical device to marke...
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device - Featured Image

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

It doesn’t matter how great your medical device concept is—you’ll need some funding to get your idea...
How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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