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…
Software Selection Driven by increasing regulatory pressure and competition, pharmaceutical companies are starting to adopt PLM (Product Life Cycle Management) software. Choosing the right software…
Life cycle management Life Cycle Management (PLM) includes the entire lifecycle of a product – from its conception, through design and manufacture, to service and…
Pharmacovigilance Within the European Economic Area (EEA) life science companies are obliged to have an appropriate system of pharmacovigilance in place.QbD Austria helps you establishing…
Artwork and labelling Artwork and labelling play an important role in the marketing process of any pharmaceutical. The advertising and labelling texts for prescription and…
eCTD The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Full or partial outsourcing to a proven…
Submissions Irrespective of the type of your regulatory procedure your applications for marketing authorisation must be accompanied correctly by the required documentation. QbD will help…
Regulatory Compliance The pharmaceutical and medical device industries are highly regulated sectors. QbD’s life sciences experts help you to achieve full compliancy. Why QbD Group?…