Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

How to Escape the Lure of Legacy Quality Management Systems

By Jon Speer on July 12, 2020

Many device professionals in small to medium-sized businesses (SMB) still use legacy systems to supp...

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020

Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

By Nick Tippmann on June 17, 2020

Are you discouraged by all of the negative news and sad stories about COVID-19? Let's shift the focu...

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020

Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020

What is a regulatory strategy? What are the components involved?

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

By Jon Speer on May 24, 2020

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device qua...

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

By Jon Speer on May 3, 2020

The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies arou...

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

By Jon Speer on May 3, 2020

Medical device companies are among the most important players in the world’s response to COVID-19.

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

By Nick Tippmann on April 29, 2020

Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for fr...

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

By Tommy Cooper on April 19, 2020

A common dilemma for early stage medical device companies is their lack of expertise in medical devi...

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

By Jon Speer on April 5, 2020

COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spr...

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