Tissues and cells
- Providing legal advice on tissues and cells activities, patient rights, healthcare professionals’ duties/rights, authorization, record keeping, reporting obligations etc.
- Acting as Responsible Person (Tissue Order §4/5).
- Preparing, implementing and maintaining quality documentation/management systems (GxP, ICH, ISO 2700X/900X etc.).
- Preparing and executing internal/external audits (ISO 19011).
Data protection
- Preparing, implementing and maintenance of ISMS/GDPR compliance-package (ISO 2700X/ 27701/29100).
- Providing legal advice and consultation on data protection, the GDPR, special law, information-/IT- and cyber security, ePrivacy, data ethics, digital responsibility etc.
- Acting as Data Protection Officer/DPO (GDPR Art 37).
- Managing of data subject rights, requests, complaints etc.
Quality management
- Preparing, implementing and maintaining quality documentation/management systems (GxP, ICH, ISO 2700X/900X etc.).
- Planning, implementing and driving the processes of risk management (EU/GxP, ICH, ISO 27005/31000).
- Registrating, assessing (root cause, CAPAs etc.) and reporting of incidents, reactions, deviations, complaints etc. (EU/GxP, ISO 13485 etc).
- Acting as Quality Responsible/quality point of contact.