LIVONDO GmbH premium healthcare – Certification audit according to DIN EN ISO 13485:2016.
We are pleased to announce that LIVONDO has once again received EN ISO 13485:2016 certification in 2019. This underlines our continuous commitment to the highest quality standards in medical technology.
EN ISO 13485:2016 is the internationally recognised standard for quality management systems in the manufacture of medical devices. It specifies the requirements for companies that manufacture medical devices or offer services in this area. The aim of this standard is to ensure that manufacturers consistently fulfil the legal and regulatory requirements in order to guarantee the safety of users and patients.
What does the certification mean for customers, i.e. for providers of medical personal lubricants or wellness personal lubricants?
For customers who order personal lubricants from us, it means that they can rely on the fact that our products and services are developed, manufactured and tested according to strict quality standards. ISO 13485 requires companies to, among other things
Risk management: systematic risk management must be implemented at all stages of product development and production to minimise potential risks to patients and users.
Documentation and traceability: Medical devices must be fully documented and traceable at all times in order to be able to act quickly if necessary.
Regular audits: Companies are subject to continuous internal and external audits to ensure that the high requirements are met at all times.
ISO 13485:2016 certification means that our customers can rest assured that our lubricating gels and other products not only meet the highest standards of functionality and safety, but also fulfil the strictest regulatory requirements.
Growing importance for the medical technology sector
In recent years, the importance of this standard has increased, particularly in Europe, not least due to the introduction of the new Medical Device Regulation (MDR), which came into force in May 2021. This regulation significantly tightens the requirements for manufacturers of medical devices and demands seamless quality assurance. ISO 13485:2016 helps compa
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