“Providing Regulatory Solutions & Quality Systems
                            for the Medical Device Industry"
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“As quoted by a recent start-up company who worked with REGSolutions to achieve ISO 13485 certification and CE marking; “Working with REGSolutions has ensured that I have strong, smart regulatory and quality frameworks in place for these diverse projects. You have been instrumental in helping establish a high performing quality system, and participating in regulatory applications that are efficiently submitted and successfully cleared.” K. W. Vice President, Business Development
    Take a look at the services we offer. How can REGSolutions help your company?

REGSolutions can help you with:

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




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

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

          Penny Northcutt