Medical device audits can be a major headache for health product developers and manufacturers. But what exactly are the audit requirements for international markets, who will comply with them, when and how? A medical device audit is a systematic and documented process designed to obtain evidence and assess whether a product has been developed in accordance with regulatory requirements. They can be both announced and unannounced by notified bodies and government agencies. But they must also be implemented internally as part of our company's ongoing regulatory obligations.

At the next Lessons Learned, organized by CataloniaBio& HealthTech, on 22 November, we have invited three experts in regulation who will share their knowledge and guide us on how to ensure that our teams have preparation plans for the exams and have the digital tools to respond in the most effective way.

Welcome by Javier Selva, CEO of CataloniaBio & HealthTech.

Moderadora: Cristina Batlle Edo, Cap d’Àrea de Sanitat a Catalunya (Delegación del Gobierno)

Ponents:

• Àngel Alonso, CEO de Vecmedical
• Juan Vicente Gómez, Regulatory Affairs & Quality Assurance Manager, GoodGut
• Anna Cortina, Directora de QA&RA i Recerca, Avinent

Programme

With the collaboration of Acció.

Follow us on Twitter with the hashtag #LessonsAudit

For: researchers and companies in the medical/health technology area.

Language: Catalan/Spanish

Registration:

• CataloniaBio & HealthTech members: free
• Non-members: €50 (VAT not included). You will be invoiced €50/person.

Questions: Imma Esposito (Project Manager) · imma.esposito@cataloniabioht.org

What are Lessons Learned?

The Lessons Learned sessions, which kicked off in 2014 promoted by CataloniaBio & HealthTech, are a knowledge forum for professionals in the health and life sciences arena to share experiences and reflections with experts on various strategic areas to boost the competitiveness of companies. The Lessons Learned sessions are also a great opportunity for networking.