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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