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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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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.
Maria
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.
Soledad
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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GPSR Services
A Canadian electronics company expanded into the EU market with AF Pharma's GPSR services, boosting Amazon sales by 40% within six months.
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GPSR Responsible Person
AF Pharma’s EU Responsible Person services ensure compliance with GPSR, helping businesses navigate EU regulations and maintain market.
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AF Pharma’s UKRP Services for Norway
AF Pharma’s UKRP services helped a Norwegian medical device company enter the UK market swiftly, boosting UK sales by 35%
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GPSR
AF Pharma offers EU Responsible Person services to ensure compliance with the GPSR, helping businesses navigate EU regulations.
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EC Rep Now
AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.
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