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Vision28

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Vision28 offers the medical device quality assurance and regulation services you need to ensure compliance with FDA regulations. With over 20 years of experience in the medical device quality assurance and regulation industry, as FDA Consultants Medical Devices we can assist you with… Writing 510(k)s for complex electro-mechanical devices and Software as a Medical Device Preparing facilities and training employees to optimize FDA and ISO inspection and Quality Audit outcomes Responding to FDA and ISO inspection observations by creating remedial action plans and preparing responses that anticipate potential objections by the agencies Writing, implementing, managing and defending ISO, FDA, CMDCAS quality systems Implementing fully compliant Quality Management Systems in three weeks or less.

Company Details

Address
Redmond, OR 97756

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Categories

Regulatory & Quality Control > ISO 13485 Consultants
Regulatory & Quality Control > Process Validation, QC
Regulatory & Quality Control > Regulatory Compliance Consultants
Regulatory & Quality Control > Risk Management
Testing > Clinical Evaluation Services
Med Device Med Rect 4.30.26
MedDevice_3:1_8.1.20
Med Device