Quality Management Systems & Audits
Auditing
As lead auditors holding training certificates from the British Standards Institute, we help our clients to adhere to ISO 13485 and ensure they meet the stringent QMS requirements for the medical devices industry.
What we do
QMS Templates
Working in accordance with ISO 13485, we have developed quality management system templates that suit your needs and compliance requirements.
Requirement Identification
Our team assesses and identifies the regulatory requirements within your QMS, considering both the UK and EU Medical Device Regulations (UK MDR / EU MDR).
Audit Preparation
Alongside helping with non-conformities in your data, we assist you with the various stages of audit preparing including:
- Stage 1
- Stage 2
- Surveillance
Internal & External Audits
We provide the benefits of a full auditing system for your deliverables, providing both internal audits and 2nd party audits of suppliers.
Consult our team
Talk with our expert auditors for assistance about your QMS and audit preparation.