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samuelpeter172

Samuel

@samuelpeter172

Medical Device Regulatory Documentation Specialist Profile Description

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Hello, I am Samuel, a biomedical engineering graduate and regulatory specialist helping med-tech companies clear compliance hurdles. I specialize in reviewing, repairing, and auditing medical device technical files, ISO 13485 SOPs, and GSPR checklists for FDA and EU MDR submissions. Having audited dozens of technical dossiers, I know exactly what notified bodies look for. Whether you need a gap audit or a full file update, I deliver audit-ready documentation tailored to your device. Let's make your device compliant... Lee más

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samuelpeter172
Samuel
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I will repair technical documentation and technical files for medical device