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A notified body’s perspective on the clinical evaluation requirements under the MDR
This article looks at the main requirements for clinical evaluation under the MDR and offers advice, from a Notified Body's perspective, on how to meet those requirements.
EU MDR and IVDR: unique device identification
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 and endocrine disruptors
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).
The convergence of the pharmaceutical and medical devices industries
Find out more about the different categories of combination products within the EU along with the regulatory pathways designed to ensure they are safe and perform as intended.
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.