Quality Management System
Our QMS Services
- We specialize in setting up and customizing Quality Management Systems (QMS) compliant with ISO 13485:2016.
- Our approach ensures that your QMS meets the specific requirements of your role in the industry and addresses the unique characteristics of your products.
- We have solid knowledge of QMS implementation for both the Medical Device and the Pharmaceutical industry.
- A Quality Management System (QMS) is more than just a binder full of protocols and meeting the rules.
- When implemented well, it improves consistency, reduces risk, and builds trust in your final product.
The scale of a QMS depends on the business
- A small MedTech startup might rely on basic document control and training logs.
- A large manufacturer may use a complex digital system that handles hundreds of procedures, approvals, and regional requirements.
Our QMS services include
- Document Templates
- Customization of QMS
- Comprehensive Documentation Package
- Documentation Editing
- Staff Training
- QMS Maintenance Planning
- Audit & Certification Support
Auditing for QMS and Technical File
- We recognize that auditing is a critical component in maintaining the integrity and effectiveness of your QMS and technical files.
- We offer both internal and external audits
Outsourced QA Manager
- Acting as an external quality manager consultant, we align our approach with the rigorous standards set by the EU Medical Device Regulation (MDR).
- Our focus is on maintaining and enhancing your Quality Management System (QMS) and technical files, which are critical for regulatory compliance and product excellence.
Our Outsourced QA Manager services include:
- Strategic Regulatory Compliance
- QMS Oversight – meeting EU MDR standards, continuous improvement
- Risk Management
- Clinical Evaluation and Post-Market Activities
- Audit Management
- Documentation Management
- Incident Management and Reporting
Equipment Qualification
We have combined more than 100 years of experience in performance of validation of production equipment.
Our Services include:
- Equipment specification preparation (URS)
- Performance of equipment risk assessments (FMEA / HAZOP)
- Preparation of validation plan
- Preparation of qualification protocols (IQ, OQ, PQ)
- Preparation of qualification report, fulfilling the authorities' expectations (US, EU and rest of the world)
- Preparation of SOP's
- Equipment cleaning qualification/validation