Guiding Your Firm Towards Greater Heights
We Offer Excellent Quality Management Consulting Solutions
A Consulting Company That Helps You Succeed
Services
ISO13485, MDSAP, MDR, UKCA
REGULATORY STRATEGY,
QUALITY MANAGEMENT SYSTEM STRATEGY,
AUDITING AND INSPECTION,
REGISTRATION AND LISTING
COMPLIANCE AND REMEDIATION,
RISK MANAGEMENT,
TRAINING
Our Consultants, Auditors, and Trainers are highly qualified, experienced and trained to the latest requirements of the ISO13485, MDSAP, MDR, UKCA, FDA 21CFR.
All of them approved with 5+/10+ years of experience in the Notified Body/Registrars (BSI, SGS, NSAI).
01 REGULATORY STRATEGY
01 REGULATORY STRATEGY
MDSAP, MDR, UKCA implementation, certification, maintenance
Full consulting services, including Post Market Compliance
Quality Management System Development, Implementation, and Certification:
Implementation QMS system including related regulatory requirements.
Regulatory Affairs:
Internal Audits, Mock Audits, Gap Audits, Supplier Audits
Registration and Listing
Support with Company and medical devices registration, licensing and certification.
Compliance and Remediation
Support ensuring company and product compliance to all applicable regulatory requirements.
Help with Regulatory Agencies Inspection Findings
Risk Management
Implement Risk-based approach in the QMS
TRAINING
ISO13485, MDSAP, MDR, UKCA, RISK MANAGEMENT, INTERNAL AUDIT.
Highly qualified consultant
Highly Qualified Consultants
We know that learning is easier when you have an excellent presenter. That's why most of our trainers have achieved an advanced degree, best in industry training and approvals, which includes also related working experience in their field. Our instructors are passionate about the subjects they teach and bring this enthusiasm into their seminars and courses.