Medical Devices

Jeiven Pharmaceutical Consulting, Inc. specializes in providing regulatory, product development and quality systems consulting services to sponsors and/or manufacturers of medical device/in-vitro diagnostic (IVD) products as well as combination drug/device products. We can also help our clients (small or large) with development of  505(b)(2) regulatory strategy, preparation of FDA submissions (510(k), IDE, PMAs), product manufacturing and testing, biocompatibility, software, clinical trial design and evaluation, and Quality System Regulation (QSR) regulatory compliance. Our help includes development issues, including preclinical data requirements, clinical trial design, device regulatory strategy development, and device testing design. We have significant experience in developing Quality Systems documentation, implementation of quality systems and training of staff as required for compliance with 21 CFR 820. We are able to provide auditing services related to performing GMP audits of manufacturing facilities, processes and quality systems globally including supplier and contract manufacturer audits.

  • Technical Support for Product Development
  • Establish / Evaluate Quality Systems 
  • Set-up Audit Design History File (DHF)
  • Assist in Design Transfer for Manufacturing 
  • Clinical Trial Project Management
  • Assemble CMC 510(k) Submission 
  • Risk Analysis / Hazard Analysis 
  • Due Diligence of New Technologies
  • Establish Development and Regulatory Strategy
  • Intellectual Property Evaluation
  • Assist in Identifying / Qualifying Manufacturers 


Medical Device Training

 

This foundation program presents the essentials of the device GMPs or Quality System Regulations (QSR, 21 CFR 820), and is designed to promote employee compliance. Topics will include (but not be limited to):

  •  A short history of the FDA and drug and device regulations
  • The inspectional role of FDA and its device regulatory sanctions
  • Key elements of the QSR
  • Quality System elements essential to the US FDA and international regulatory bodies
  • Internal and contractor audits
  • Device risk analysis
  • SOPs: authoring, reviewing, approving, and training
  • Good device documentation practices
  • Production and process controls: 
    • Equipment controls
    • Automated process controls
    • Validation/qualification
    • Acceptance criteria
    • Labeling, packaging, storage, and distribution
  • Management Quality Controls and responsibilities including:
    • Management commitment
    • Authority
    • Communication
    • Review
  • Design Quality Controls (QbD), including change control
  • Production and Process Quality Controls
  • Complaint handling
  • Medical device reporting to FDA
  • Device failure investigations
  • Establishing CAPA (Corrective and Preventive Action) initiatives
  • FDA’s QSIT (Quality System Inspection Technique) and preparing for an inspection
  • QSIT vs. ISO (13485:2003/9001:2000) inspections
  • Review of QSIT FDA 483s and Warning Letters (class exercise)

Address :

6 Jacobs Lane
Scotch Plains, New Jersey 07076