Quality Management Systems

		Build and implement quality management systems (QMS) compliant with ISO 13485, FDA cGMP, MDD, and
		Canada/SOR requirements
		Perform QMS Gap analysis
		Provide QMS Standard Operating Procedures and training
		Develop Adverse Event, Vigilance Reporting, and Complaint Handling Systems
		Develop and implement Design Control systems for speedy product development

USA Medical Device Product Clearance and Approvals

		Regulatory strategies for approval pathways
		Regulatory classification assessments
		US medical device approvals (PMA, HDE, Pre-IDE and IDE/IRB, 510k, 513g and DeNovo submissions)
		Correspondent with FDA during submission process

International Submissions

		Europe (EU) Design Dossier & Technical File development
		Medical Device Directive CE Mark guidance
		Canada registrations

FDA Liaison

		FDA inspections assistance
		Representation for regulatory compliance issues
		Warning letter responses
		Product recall assessments and liaison with suppliers

Clinical Services

		Create and implement clinical strategies for product development
		Pre-IDE and IDE/IRB submissions
		Clinical literature review for MDD compliance
		Clinical Risk/Benefit Analysis
		Clinical Quality Management Systems

ISO Certification

		Lead companies through ISO certification efforts
		Interface with Notified Body and Authorized Representatives

Auditing

		ISO certification readiness audits
		Internal quality system audits
		Supplier audits
		FDA QSIT preparation audits

Let’s talk today about how REGSolutions can help you.