Category: Uncategorized
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Audit Proof Your Quality System: Expert Tips to Avoid Frequent MDSAP Non-Conformances
Whether your medical device company is new to the MDSAP program or has participated for a few years, audits present an opportunity for continuous improvement of your quality system. However, audit findings can lead to lengthy corrective actions and major costs, so proactively avoiding pitfalls is critical. This post highlights common mistakes and potential non-conformances…
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BioSpace Posts MedLark Press Release
MedLark Press Release Live on BioSpace- MedLark Aims to Support Women in Healthtech BioSpace posted a press release on our firm today! The full release can be viewed by clicking the button below. In a quote from our CEO, Resham described the firm’s goals: “We provide strategic support tailored to each client’s unique needs, whether…
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UK Guidance for Post Market Surveillance- How Does It Compare to EU MDR?
Release of the UK draft Last week brought an important update for medical device manufacturers- the UK released a new draft guidance outlining requirements for post-market surveillance. The guidance was published alongside a request for public feedback over the next 60 days. Per the World Trade Organisation, the draft will likely be finalized this winter…
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FDA Seeks to Expand Access to At-Home Medical Devices
The U.S. Food and Drug Administration (FDA) is looking for ways to increase access to medical devices intended for use outside of traditional clinical settings, such as in the home. In a recent request for public comment, the FDA asked for feedback on how it can better support the development and availability of technologies like…
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Update on EU MDR Harmonized Standards: Ensuring Compliance and Safety
Introduction The European Commission recently issued an important update to the Harmonized Standards incorporated within the EU Medical Device Regulation (MDR) on July 4, 2023. This regulation update, known as Implementing Decision (EU) 2023/1410, introduces modifications to the existing inclusion of EN ISO 25424 and adds a new standard, EN ISO 10993-10. In this article,…
Medical Device Consultant | Regulatory & Quality System 