What Are the Biggest Changes under EU MDR?
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Why You Must Have a Single Source of Truth for CAPA
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic
As COVID-19 sweeps the globe, it’s becoming increasingly difficult for medical device leaders to navigate the arising challenges and prepare for the future.
COVID-19’s Impact on the MedTech Industry:
How to Get Through
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
Engineers:
How to Curb Quality Myths Now
The most successful medical device companies have the same characteristic in common: They’re cross-functional. Whether it be the device design and development activities or quality and regulatory affairs, every operation works together to produce and market medical devices that improve patients’ lives.
Paper Processes: Three Reasons It’s a Costly Business Move
Both paper and digital paper are outdated approaches to medical device quality management.
4 Keys to Funding Your Medical Device
How will you make your company more attractive to investors?
Top 3 Mistakes You Can Make When Adopting ISO 13485
Drop the checkbox mentality and embrace accountability and understanding.
Understanding FDA’s Guidance on Medical Device Reporting
How in touch are you with current MDR guidelines?
7 Steps to Respond to FDA 483 Inspection Observations
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
