With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
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.
The continued threat and spread of COVID-19 across the globe has led to seismic uncertainty for every industry.
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.
Both paper and digital paper are outdated approaches to medical device quality management.
How will you make your company more attractive to investors?
Drop the checkbox mentality and embrace accountability and understanding.
How in touch are you with current MDR guidelines?
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.