Both paper and digital paper are outdated approaches to medical device quality management.
How will you make your company more attractive to investors?
The report also found that medical device companies are taking “huge gambles” in the area of risk management.
Drop the checkbox mentality and embrace accountability and understanding.
Going paperless is easier than you think.
Although designed for software, Agile’s fundamental values are equally relevant to medical devices.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
It is one of the most basic of quality requirements.
Think outside of the box and approach your QMS with passion and creativity.
Manufacturers must re-evaluate existing regulatory and compliance strategies to meet the new requirements.