Call Us at +1 (517) 242-8199
or Email us at: Customer.service@baldridgeconsulting.com
We offer multiple services to fit your needs
Quality System Design and Implementation
Full QMS Implementation to support; ISO 9001, ISO 13485, MDSAP, CMDR, 93/42/EEC, 2017/745 and several others
ISO 9001 Transition to ISO 13485 Preparation
2017/745 MDR Transition Preparation & Audit
MDSAP Transition Preparation & Audit
Pre-Certification Gap Analysis for a variety of standards including 9001, 13485, As9100C, IATF16949, MDR, MDSAP.
Mock FDA audit
Mock Unannounced CE audit
"ON DEMAND" Regulatory services
Review Regulatory Submissions
Licensing and Registration for Devices
Regulatory Reporting
Regulatory Environment Monitoring (PMS)
Assist or facilitate notified body audits
Create and maintain regulatory SOP's and WI's
Manage Regulatory Reporting; MDR, Vigilance, etc..
Maintain Recall & Advisory systems
Training Services
Internal Auditing
Lean Concepts
Corrective Action/ Preventive Action
Customer Complaint Handling