QA/RA Compliance Footprint

Expert solutions for your medical device quality and regulatory needs.......

Partner with us for expert QA/RA consultancy services, with affordable and flexible solutions helping you define and maintain both the quality and regulatory footprints for your medical devices.

Meeting your quality and regulatory needs to ensure your medical devices comply with applicable international standards and regulatory requirements, and devices are safe and effective for patient use.

Partner to define your

Quality Footprint

QMS Fit for purpose : establish and maintain (gap analysis)

eQMS implementation specialist - Cognidox Certified Partner

Notified Body/Certification Body partner

Remediation guidance and resourcing

Training provider for your ISO and QMS training requirements

Auditing:

Internal - identifying improvement opportunities and employee compliance,
External - Supplier Qualification, and
ISO Notified Body/Certification Body

Partner to define your

Regulatory Compliance Footprint

Device classification and applicable regulatory requirements - determine these for your device?

Regulatory strategy - Create to take product to market in the chosen country and region

eQMS implementation specialist - Cognidox Certified Partner

Documentation Specialist:

compilation of Technical File/Design History File preparing for regulatory submission
Assisting with the regulatory submission process, product and site licensing registration
Preparing for and hosting regulatory authority inspections (PAI) and working on remediation activities