​KNOWLEDGE BASE:

BENEFITS OF CHOOSING

BALDRIDGE CONSULTING:

• Full QMS Implementation - ISO 9001:2015, ISO 13485:2016, MDSAP, MDR 745/2017 and several others
  
• Pre-Certification Gap Analysis for a variety of standards including 9001, 13485,​ MDR, MDSAP and more.
  
• Building of Techinical Documentation for MDR and RoW
  
• Building of Design History Files for FDA
  
• Create and maintain regulatory SOP's and WI's
  
• Mock FDA audit
  
• Mock Unannounced CE audit
  
• Performing Internal Audits to client’s procedures & required regulations
  
• Review Regulatory Submissions and associated activities
  
• Licensing and Registration for Devices
  
• Regulatory Reporting
  
• Regulatory Environment Monitoring (PMS)
  
• Author Clinical Evaluation Plans (MDR)
  
• Author Clinical Evaluation Reports (MDR)
  
• Assist or facilitate notified body audits
  
• Manage Regulatory Reporting; MDR, Vigilance, etc..
  
• Maintain Recall & Advisory systems
  
• PRRC for clients to EU and other international bodies

• 20+ years in manufacturing environments, quality & regulatory
  
• Personalized project planning
• Maintain correspondence with clients in a clear concise fashion, rapid response rating, 24 hours or less
  
• ​Remote or On-site service
• Flexible invoicing and payment plans
• Tailored Project planning
• Free quotes

• ​​Standards trained in (or certified for): FDA QSR, ISO 9001:2015, ISO 13485:2016, MDD(maintenance), MDR, MDSAP, ICH Q9 – Q13​
• ​Advanced Leadership Training 
• Layered Process Auditing
• MiniTab Power User
• Egnyte Administrator
• Greenlight Guru Administrator
• Made2Manage Power User
  
• ASQ-CQA
• QS 9000
  
• IATF16949
  
• AS 9100
• GxP Self Inspections
• CER under MDR.

Training & Mentoring, Quality Consultant for ISO and FDA

Nicole is also our lead quality consultant. Nicole has worked within the regulatory and quality environment for over 20 years. She has a background ranging from ISO 9001 to ISO 13485 and everything in between. She is certified Lead Auditor for multiple regulations and spent 6 years as a Lead Assessor, mentor and trainer with BSI. She has implemented and run quality systems in both the automotive sector as well as the medical device field.

Proverbs 3:5-8 "Trust in the Lord with all your heart, and do not lean on your own understanding. In all your ways acknowledge him, and he will make straight your paths. Be not wise in your own eyes; fear the Lord, and turn away from evil. It will be healing to your flesh and refreshment to your bones."

OFFERINGS: