Ringby Regulatory Affairs

Ringby Regulatory Affairs can support the company in coorporation with the company through the different stages in the development of medical devices. Some products will require that Ringby Regulatory Affairs coorporate with other experts.

Strategy/Claims: Regulatory strategy, classification, claims.

Coordination: Contact to the relevant authorities, specialists, suppliers etc.

Requirements: Evaluation of requirements to the documentation from the relevant authorities inclusive verification/validation of the products.

QA: Implementation of quality procedures, internal audits.

Clinical Evaluation: Preperation of literature search, evaluation of clinical data.

Risk management: Risk management activites inclusive post-production information( post marketing surveillance/vigilance).

Biological Evaluation: Preperation of biological evaluation for products that are in contact/indirect contact with the body. Inclusive toxicological evaluation, based on literature search.

Labelling: Requirements for labeling, evaluation of labeling.

Informations for use: Requirements for user guidance, evaluation of user guidance.

Marketing material: Requirements for marketing material, evaluation of marketing material.

Access to the market: Classification/Reimbursement