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Medical Device Blog
Medical Device Regulations ensure safe, effective, and innovative healthcare tools by governing their design, manufacturing, and marketing
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Digital Health in Germany
Germany’s digital health sector is booming, but navigating market access, regulatory compliance, and reimbursement pathways is challenging.
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Nanotechnology Based Medical Products
Nanotechnology is transforming medicine, but regulatory classification remains complex.
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Swissmedic PMS
wissmedic’s 2025 focus campaign reviewed 30 legacy medical devices from non-Swiss manufacturers, revealing widespread non-compliance in PMS
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Digital Medical Devices
The EU regulatory landscape for Digital Medical Devices (DMDs) is evolving, incorporating the MDR, IVDR, AI Act, and HTA Regulation.
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Medical Devices in the UK: New Guide for Manufacturers
The UK medical device regulatory framework is based on UK MDR 2002, with oversight by the MHRA.
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PRRC IVDR
Ensure IVDR compliance with AF Pharma's PRRC services! From Article 15 duties to PMS and vigilance, we provide expert support for your IVD.
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FDA Q-Sub
Streamline FDA approvals with Q-Sub & 513(g)! Get early guidance on studies, pathways, and compliance. Partner with AF Pharma for experts
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IVDR template
Stay ahead with IVDR 2025 updates! Streamline compliance, enhance safety, and simplify processes with AF Pharma's expert support.
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Amazon EU Compliance
Selling Lifestyle Products on Amazon EU Compliance and Market Readiness with AF Pharma Amazon’s European marketplace is a hub for...
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Notified Body Certification
Streamline MDR certification with AF Pharma! From pre-application to post-certification, we simplify compliance for seamless EU ma
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Article 16 MDR
AF Pharma ensures compliance with MDR Article 16, offering support in regulatory assessments, QMS, documentation, and notified body liaison.
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Amazon GPSR
Amazon GPSR compliance for selling in the EU
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UKRP
Ensure MHRA compliance with AF Pharma's UKRP services! From registration to UKCA marking, we simplify UK market access
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PRRC MDR
Ensure MDR compliance with AF Pharma's PRRC services! From Article 15 duties to PMS and incident reporting, we streamline your EU products.
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Amazon's Requirements
Expand your business on Amazon EU with AF Pharma's regulatory expertise.
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MHRA PMS
Ensure MHRA PMS compliance with AF Pharma! From PMS plans to PSURs, we simplify surveillance, incident reporting, and corrective actions.
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AU Sponsor
AF Pharma is now your trusted Australian Sponsor, ensuring TGA compliance, ARTG registration, and seamless market access for your products!
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EC Rep
Appointing an EU Authorized Rep is vital for non-EU manufacturers. AF Pharma ensures compliance, documentation, and seamless EU market!
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Cosmetic registration
EU cosmetic compliance ensures safety, quality, and trust. AF Pharma guides brands through regulations, from safety assessments to market.
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GPSR Registration
GPSR ensures EU product safety with stricter risk, traceability, and surveillance rules. AF Pharma offers expert support!
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