Development activities in young organizations focus on the establishment and/or improvement of the quality system (ISO 13485): an essential requirement to bring products to market.
The quality system focus on the design phase of the product, to identify the applicable ISO-standards, to perform all required pre-clinical assessments, to assure appropriate risk management (ISO 14971), to assure appropriate set up of a documentation system to establish to product master files....
FAKKEL helps you to take a fresh look at your concepts and to pinpoint critical elements of developments in view of customer and regulatory requirements.
FAKKEL helps to wrap up the required data/results in a submission dossier ready for regulatory review and get ISO 13485 certification.
FAKKEL will advise your organization to improve the performance of your clinical department and/or helps you to assess the efficiency of the CRO you are working with.