top of page
Donating Blood

Medical Devices

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

 

CFR Compliance LLC™ believes that medical device performance must go beyond proving safety and effectiveness in a single product. It must be an organizational effort that ensures that the entire product life cycle is reliable and sustainable for the patient. 

​

We assist clients in early development activities with regulatory submissions and engineering, as well as post market activities for commercially approved devices. Our highly qualified staff will assist with each requirement established by EU MDR, ISO 13485, US FDA, and international Ministries of Health. Some of our services: 

​

Regulatory Affairs and Strategy

  • IDEs

  • Technical Files

  • Traditional 510k

  • Special 510k

  • Abbreviated 510k

  • Catch Up 510k

  • PreMarket Approvals (PMA)

  • Humanitarian Device Exemption (HDE)

  • Unique Device Identification (UDI and GUDID) 

​

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

  • Remediation for Form 483, Warning Letter and Consent Decree

  • CMC and drug specification development

  • PreApproval Inspections (PAIs)

  • Process/Product Transfer and Engineering

  • Process Validations

  • Supply Chain and US Customs Compliance 

  • GMP Inspection support 

  • Post Market Surveillance

  • Risk Management Reports

  • GMP Training 

  • Quality Engineering

bottom of page