Smestad & Associates offer services to support FDA and EU regulatory and compliance needs. We supply reliable, on-target and practical solutions throughout medical device design and development and post-approval phases including regulatory submissions and regulatory compliance and quality. We can help guide you to meet the requirements of QSR (21 CFR 820), cGMP and ISO 13485.
Design and Development
Design Control Implementation
Risk Management
Establish risk management programs (EN 14971)
Risk Analyses
Fault Tree Analyses
Failure Modes Effects Analyses
Level of Concern Analyses
Regulatory Affairs
Product strategy
Regulatory Submissions such as 510(k)s and CE Marking
Responses to FDA actions
Regulatory compliance
Quality System Implementation
Quality System Regulation (QSR) - 21 CFR 820
ISO 13485
ISO 9001
Internal and Supplier Auditing
Facilities, Equipment and Process Validations
Installation qualifications
Operation qualifications
Performance qualifications
Sterilization validations (gamma/steam/aseptic process)
Software/Hardware Validation