Download the latest medical device whitepapers and articles below to help you perform better, reduce risk and make excellence a habit in your organization.
Using standards to demonstrate conformity
The application of standards in the medical devices sector has undoubtedly been accelerated by their use to support regulation by providing a voluntary means to demonstrate conformity with regulatory requirements.
This white paper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.
Phthalates are plasticizers that impart flexibility to plastic products and can leach into their surroundings. Many phthalates have the potential to cause hormonal disruption. This white paper summarizes the evaluation of phthalates and endocrine-disrupting (ED) substances in medical devices (MDs).
Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15
With the MDR and IVDR, European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements.