GBA Key2Compliance®’s Post

If you have a legacy medical device on the European market that isn’t yet CE-marked according to the Medical Device Regulations (MDR), this is crucial information for you! The transition from the Medical Devices Directive (MDD) to MDR has been extended. Stay informed about the latest timelines to ensure uninterrupted product sales. Check out this easy-to-follow summary that covers everything you need to know! Need help navigating the regulatory landscape? Let’s discuss how we can support you in successfully fulfilling the EU MDR 2017/745 requirements. Remember, compliance ensures patient safety and market access. Let’s make your medical devices MDR-ready! 💡 Key2Compliance #mdd #mdrcompliance Read more

Staying compliant with international standards is critical in the medical device industry. ISO 20417:2021 is a crucial standard outlining the information manufacturers must supply with medical devices. Why This Matters for Medical Device Manufacturers: Adhering to ISO 20417:2021 not only ensures regulatory compliance but also enhances product transparency and user trust. Understanding and implementing these requirements is vital for maintaining market access and achieving global success. Artixio's Expertise: At Artixio, we specialize in guiding medical device manufacturers through complex regulatory landscapes. Our expert team provides customized solutions for compliance, documentation, and market entry strategies to help you meet international standards with ease. Read the full blog here: https://lnkd.in/gq6nzQV3 #MedicalDevices #ISO20417 #RegulatoryCompliance #MedTech #ProductSafety #MarketEntry #MedTechInnovate #ISOStandards #15223

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/eaRh632R

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/e4NXKsS3

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/gwj6uVP8

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts Patterson (Pat) Shafer and Ancy J. walk through the key advantages of integrating mock recalls to optimize recall execution:

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/eBHmJAzr

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/d8WWVXQA

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/egmXF7Ak

In 2023, the FDA reported 975 recalls for medical devices, affecting everything from simple instruments to complex implantable devices. A recall can tarnish brand credibility, constrain healthcare providers, and compromise patient health and safety. Our experts walk through the key advantages of integrating mock recalls to optimize recall execution: https://lnkd.in/eN8DiKkR