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Medical Devices

A medical device is defined as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar article, including any component part or accessory, that is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions."

CFR Compliance LLC™ believes that ensuring medical device performance extends beyond demonstrating safety and effectiveness for a single product. It requires an organizational commitment to maintaining reliability and sustainability throughout the entire product life cycle.

We support clients with early development activities, regulatory submissions, and engineering, as well as post-market activities for commercially approved devices. Our experienced team ensures compliance with requirements set by EU MDR, ISO 13485, US FDA, and international Ministries of Health. Some of our services include:: 

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Regulatory Affairs and Strategy

  • IDEs

  • Technical Files

  • %10k (Traditional, Special, Abbreviated, and Catch Up)

  • PreMarket Approvals (PMA)

  • Humanitarian Device Exemption (HDE)

  • Unique Device Identification (UDI and GUDID) 

  • EU MDR and International Technical Files 

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Good Laboratory Practices - GLP

  • PreClinical QA and GLP operational support

  • NonGLP and GLP QA Systems Implementation 

  • Study Protocol Drafting 

  • Test Article, Vivarium, Necropsy, Histology Auditing

  • GLP Training  

 

Good Clinical Practices - GCP

  • Clinical QA and GCP Systems Implementation

  • Clinical Operations Support for Site Initiation and Enrollment

  • Onsite Clinical Monitoring

  • Clinical QA Audits

  • IRB participation and auditing

  • CDCRs GCP Training for Sponsors, PIs and CROs 

 

Good Manufacturing Practices - GMP

  • Fractional Quality Management Services

  • Remediation for Form 483, Warning Letter and Consent Decree

  • CMC and drug specification development

  • PreApproval Inspections (PAIs)

  • Process/Product Transfer and Engineering

  • Process Validations

  • Supplier Quality Management and Auditing

  • GMP Inspection support 

  • Post Market Surveillance

  • Risk Management Reports

  • GMP Training 

  • Quality Engineering

Need more details?  We are here to assist. 
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