The purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.
We support with Incident Report Management (IRM) and/or Quality complaints including: Incident processing, Medical Review, QC and submission in different countries.
When are EU vigilance reports required? The term "vigilance report" encompasses Incident Reports and Field Safety Corrective Action (FSCA) reports.
According to MEDDEV guideline, an incident report must be filed if a device malfunction, deterioration in device performance, inadequate instructions, or inadequate labeling results in death or serious injury, or may lead to death or serious deterioration in state of health if it were to recur. The incident must be reported to the Competent Authority (CA) of the member state where the incident occurred. We have experience assisting manufacturers with post-market surveillance, so our team is constantly involved in helping companies with medical device vigilance reporting.
DeltaPV supports cosmetic companies in managing their regulatory obligations in the area of cosmetovigilance, in general-case processing.
Unlike medicines, which are used to treat or prevent a disease in the body, cosmetics are not thought to change or affect the body’s structure or functions and as a result the requirement for Risk assessments and monitoring potential consumer harm has not been a priority. This means that the safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the general public.
Cosmetovigilance is defined by the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product. Together with other tools, cosmetovigilance contributes to post market surveillance.
DeltaPV provides comprehensive management of adverse effects of cosmetics reported by consumers, health professionals or authorities, data entry, submission, periodic literature search, Recall procedures of a marketed cosmetic Product and audits to cosmetovigilance system
Veterinary pharmacovigilance concerns monitoring, evaluating and improving the safety of veterinary medicines, with particular reference to adverse events in animals and human beings related to the use of these medicines. It also involves collection of information on adverse events due to off-label use and investigations of the validity of the withdrawal period and of potential environmental problems
DeltaPV offers a comprehensive veterinary safety reporting system that is compliant with related specifications. Veterinary drug manufacturers collect, assess, and report adverse events in accordance with the regulatory obligations. With full electronic Reporting and provision to generate different report outputs
DeltaPV offers an easy way to comply with the latest regulations .