Smestad & Associates LLC offer services to support FDA and EU regulatory and compliance needs for medical device companies. We supply reliable, on-target and practical solutions throughout medical device design and development and post-approval phases including regulatory submissions, regulatory compliance and quality. Smestad & Associates LLC can help guide you to meet the requirements of QSR (21 CFR 820), ISO 13485:2016, ISO 9001:2015, Medical Device Regulation, Medical Device Directive, Japanese Pharmaceutical Affairs Law (JPAL) and Canadian Medical Devices Regulations (SOR/98-282).
Design and Development
Design Control Implementation
Design Assurance
Project Management
Risk Management
Establish risk management programs (ISO 14971:2019)
Risk Analyses
Failure Modes Effects Analyses
Level of Concern Analyses
Regulatory Affairs
Product strategy
Regulatory Submissions
510(k) submission preparation and filing
Responses to FDA actions
Regulatory compliance
– responses to FDA and Notified Bodies
– preparation for FDA inspections
CE Marking
– Technical Documentation preparation and submission
– MDD/Medical Device Regulation
Quality System Implementation
Quality System Regulation (QSR) – 21 CFR 820
ISO 13485:2016
ISO 9001:2015
Medical Device Directive (MDD)
Medical Device Regulation (MDR)
Japanese Pharmaceutical Affairs Law
Canadian Medical Devices Regulations
Internal Audits
Supplier Audits
FDA Readiness Audits
Software Validation
Software requirements development
Software validation protocols
Protocol execution
Report writing
Facilities, Equipment and Process Validation
Installation qualifications
Operation qualifications
Performance qualifications
Sterilization validations