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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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Maria
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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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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Maria
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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pharmaserviceinc
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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Maria
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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Soledad
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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Maria
Amazon GPSR
Amazon GPSR compliance for selling in the EU
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Soledad
UKRP
Ensure MHRA compliance with AF Pharma's UKRP services! From registration to UKCA marking, we simplify UK market access
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Soledad
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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Maria
Amazon's Requirements
Expand your business on Amazon EU with AF Pharma's regulatory expertise.
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Maria
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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Maria
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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Maria
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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Maria
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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Maria
GPSR Registration
GPSR ensures EU product safety with stricter risk, traceability, and surveillance rules. AF Pharma offers expert support!
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Soledad
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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Maria
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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Maria
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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Maria
GPSR
AF Pharma offers EU Responsible Person services to ensure compliance with the GPSR, helping businesses navigate EU regulations.
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Maria
EC Rep Now
AF Pharma’s EU Authorized Representative (EC Rep) services help non-EU medical device manufacturers.
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