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 (EN ISO 14971:2012)
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 File/Design Dossier preparation and submission
– MDD/Medical Device Regulation

Quality System Implementation

Quality System Regulation (QSR) – 21 CFR 820
EN ISO 13485:2016
ISO 9001:2015
Medical Device Directive
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