OnaWave Medical’s Post

I have a lot of open dialog with medical device manufacturers on their product’s essential performance (EP) and how to monitor the EP as it relates to FDA, Notfied Body and other regulatory governance. Clarissa Benfield and Dr. Nirav Darji of Intertek Electrical share best parctices on this topic. #youllbeamazed #medicaldevice

Episode 30 of "Medical Compliance With Clarissa" is now live at https://lnkd.in/ehUSCe5t. This episode features host Clarissa Benfield and guest Dr. Nirav Darji, Sales Manager for Medical & Laboratory equipment at Intertek Germany. They discuss the important topic of what defines a #medicaldevice in today's world of merging technologies. They also dive into "Essential Performance" -- what it means and how to test for it. Tune in now to hear the latest episode. #medicalcompliance

🟡 𝐌𝐄𝐃𝐈𝐂𝐀𝐋 🟡 We understand what is at risk, and we’ll be happy to help you. ✅😍 Learn more about Husky Medical: https://bit.ly/3v58SaQ ✅⬇️ Download the Medical Systems guide: https://bit.ly/47wuL5e #HuskyHotRunnersControllers #HuskyMedical #HuskyControllers #InjectionMolding

The Clinical Evaluation Consultation Procedure (CECP) is a requirement of a clinical evaluation process under MDR for implantable Class III, and class IIb active devices intended to administer and/or remove a medicinal product. The expert panel provides an opinion on the Clinical Evaluation Assessment Report (CEAR) prepared by the Notified Body based on the Clinical Evaluation Report (CER) of the manufacturer if the products in question are the same class as stated in MDR Article 54 (1). However, not every notification of a CEAR results in an opinion from the panel as there is a screening stage to decide if an opinion should be provided. Annual summary of the procedure is published on the commission website.

In this final entry of our technical article on bearings used in medical devices, we examine two undesirable conditions bearings may experience in medical applications: contamination and noise/vibration. The following is part three of a three-part post. Links to part one and two are provided in case you missed them: https://bit.ly/3uOAExF

Join today's WHO webinar (Monday, 8 July 2024) to learn about nomenclature of medical devices including World Health Assembly Resolution WHA75(25).

Previous vital components of code level selection no longer factor into the level of decision-making. Instead, determining a level of service comes down to one of two components: Medical decision-making (MDM) or time. Subscribe now to learn more https://bit.ly/40wqXPz

Discover the keys to building a strong quality culture in the medical device in Teresa Gorecki's latest blog post! 💡 Learn how to tackle challenges and ensure long-term success with Quality Pulse®. https://lnkd.in/edtzuSKm #QualityCulture #MedicalDevices #BusinessSuccess #QualityPulse🏥🔍

In this current age, finding reliable guidance and information can be a challenge. It helps to be able to learn from the experiences of other medical device organisations. That is why we share the feedback we have received from clients who have chosen to trust and work with MedRAS. Take our word for it, but also take theirs. https://lnkd.in/e_vi3qSe

ICYMI, CDRH's 2023 Annual Report is out, including reference to the LDT proposed rule, expansion of TAP (the Total Product Life Cycle Advisory Program), reflection on the progress of the Digital Health Center of Excellence, and more. A good way to get caught up on FDA's activity with respect to medical devices in 2023 and prepare for what may be down the road in 2024. #FDA #medicaldevices #healthlaw #lifesciences