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.
Medical device clinical investigations — What’s new under the MDR?
This paper was first published by BSI in 2018 and has been revised in light of the publication of BS EN ISO 14155:2020. The paper discusses important requirements for pre-market and post-market clinical investigations under the European Medical Device Regulation (2017/745) (MDR), relevant European guidance documents and BS EN ISO 14155:2020, and how this updated standard can help in meeting MDR requirements.
A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation
Understanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.
Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those 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.