AlfaNordic’s Medical Device Consultants
The challenges within legislature and development via manufacture, sales, distribution and marketing are dynamic processes to be followed closely to keep your products up-to-date. AlfaNordic can assist you with expert knowledge and guidance of a high quality through all phases of the medicinal product’s life cycle. Since 2009, the regulatory authorities have directed a tightened focus on companies making use of medicinal equipment, particularly with regard to CAPAs, Design Controls, Complaint files, PPQs and procurement. This development is due to increased regulation and more stringent quality requirements. Lately, the industry has experienced an update to Eudralex, a new PPQ methodology, a generally more risk-based approach and philosophy and a new version of ISO13485.