Discover the strategic steps to global medical device compliance—because if Google can do it, so can you! Dive into our latest blog for insider insights. #MedicalDevice #Regulation #HealthTech #Innovation

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While developing your #medicaldevice and the sales plan, you will spend time determining and making careful decisions about your Target Market. The commercialisation strategy and plan should also consider the #regulatory requirements of your target markets

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IFU stands for “Instructions for Use” and every #medicaldevice must have one and it must be accessible to the end-users of the product.

Medical device manufacturers must comply with several requirements regarding the information provided with their devices.
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Embarking on the journey to launch a #medicaldevice in the USA can be daunting, given the intricate regulatory landscape and stringent requirements.

Check out this 10-step guide!

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🔗 Read more: globalregulatoryservices.com/news/nihr-i4...

#Innovation #HealthTech #MedTech #DigitalHealth #RegulatoryCompliance #Funding #Healthcare #MedicalDevices #LifeSciences #SMEs #ClinicalResearch #UKHealthcare #ResearchFunding #QualityAssurance

Dive deeper into the recent publications:

MDCG 2021-12 Rev.1: FAQs on EMDN
MDCG 2025-1: Ad hoc update procedures
MDCG 2024-2 Rev.1: Annual update procedures

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#MedicalDevices #MedTech #EURegulations #EMDN #Compliance #RegulatoryAffairs #EUDAMED #MDR #IVDR #MedDiDia

The European Union requires any foreign manufacturer from outside of the European Union who intends to place their devices must appoint an authorised representative (EC REP) with a physical address within one of the Member States.

med-di-dia.com/eu-authorise...

Regulatory strategy defines a pathway for the market access of your #medicaldevice. It helps to understand the regulations which underpin market entry to form the base of your medical device marketing function.

Let's find out if it can serve as a Marketing plan.

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AI-Driven Medical Device Regulatory Compliance: New Article by Dr. Shahram Ahmadi Published in RAPS RF Quarterly

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QMSR – Quality Management System Regulation

The #MedTech industry has until 2 February 2026 to comply with the new rule and can continue to comply with requirements under the current QS regulation until then.

med-di-dia.com/news/iso-134...

the EU, UK, and USA—have unique requirements and certification processes that ensure safety and compliance. Here’s a breakdown of the certificates from each region and factors to consider for the first market entry.
#MedTech #Compliance

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🌍 Navigating the Total Product Life Cycle (TPLC) for Medical Device Software! 🔬

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#MedicalDeviceSoftware #SoftwareAsAMedicalDevice #SaMD #RegulatoryCompliance #MedicalDeviceRegulations #ISO13485 #IEC62304 #RiskManagement #QualityAssurance #MedTech #MedDiDia

🔍 Embrace the future of MedTech with the FDA's new draft guidance on AI-enabled medical devices.

Discover more: med-di-dia.com/news/navigat...

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#MedTechInnovation #FDACompliance #ArtificialIntelligence #MedDiDia #RegulatoryExpertise

A Certificate of Free Sale (CFS) is an essential document for manufacturers and authorised representatives looking to export medical devices outside the European Union (EU). Find out more - med-di-dia.com/blog/underst...

What is one of the top regulatory challenges affecting the #MedTech industry?