Vigilance Companies bringing medical devices on the market are obliged to have an appropriate system of vigilance and post market surveillance (PMS) in place.QbD help…
Regulatory Intelligence Regulations and standards may change every now and then, and manufacturers must be aware of those changes.QbD’s consultants keep you on track at…
Artwork and labelling Artworks and labels form part of your medical device technical file. If an artwork or label is changed the corresponding section in…
Product Classification Medical devices need to be classified, following a certain set of rules.We help your to classifiy your product and set up a strategy…
Technical File Construction To obtain CE marking manufacturers must prepare and keep technical documentation that states how each medical device was developed, designed and manufactured.QbD…
Product Development A new medical device starts as an idea or significant improvement to an existing product. But before market entry, new ideas need to…
CE Marking CE marking signifies that products sold in the EEA (European Economic Area) have been assessed to meet high safety, health, and environmental protection…