English Deutsch English Gewerberechtlicher Geschäftsführer (Managing Director) For life science companies in Austria QbD can provide a licenced Managing Director to companies who produce and…
Quality Assurance QbD Austria offers tailor made Quality Management System solutions to organisations in the life science industry. Explore our advisory services Our advisory services…
Standard Operating Procedures (SOPs) SOPs are written procedures which are necessary to assure control of production and processes especially in GMP/ISO environments.QbD assists you to…
Quality Management ISO 13485 ISO 13485:2003 specifies certain requirements for a quality management system in the medical device industry. QbD’s experienced quality managers will assist…
Audits Competent authorities and certification bodies increasingly expect pharmaceutical and medical device companies to regularly audit their suppliers and service providers as well as their…
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…