Our consultants are focused and committed to incorporate top-notch quality standards into your medical device company’s daily operations. We consistently meet the various mandatory requirements of ISO 13485, FDA QSR, MDSAP, or any other applicable standards.
- 21 CFR 820 – Quality System Regulations
- 21 CFR 11 – Electronic Records, Electronic Signatures
- ISO 13485: 2016 – Medical devices Quality Management Systems
- 21 CFR 830 – Unique Device Identification
- ISO 14971: 2019 – Application of Risk Management to Medical devices
- 21 CFR 820.30 – Design Control Requirements
- 21 CFR 801 – Labeling
- CAPA
- 21 CFR 803 – Medical Device Reporting
- Internal Audits, Mock Audits
Process and Production Control
- IQ / OQ / PQ Validation
- Suppliers Quality
- Identification / traceability
- Agile, Six-Sigma, Lean Processes
Product Surveillance
- Post Market surveillance
- Risk Management
- PMCF / PMPF Risk Management
Management Responsibility
- Management Review
- Inspection Readiness
- Internal Audit
Change Management
- Design Change Management
- QMS Change Management
- Risk Review
Design Control
- DHF Remediation
- Design Input / Output
- Design Verification / Validation
- ISO 13485:2016
- 21CFR 820.30
Resources
- Personnel Competencey
- Infrastructure
- Work Environment
Corrective And Preventive Action
- Eliminate Non-conformities
- QMS Improvement
- Verify Effectiveness
SERVICES
Our Other Services
Regulatory Compliance
With our deep understanding in market authorizations, we help you with end-to-end approval processes to successfully market your products globally.
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Product Development
Our experts combine their experience and know-how to build and update your device's design history in line with the quality systems and regulatory requirements.
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History: The Medical Audit Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to allow third party auditors to conduct a single audit of a medical manufacturer that covers ISO 13485:2016 and the respective regulatory requirements. A working group was established for MDSAP in 2012. Then, IMDRF initiated a three […]
A medical device quality system is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. Most medical devices will require some form of a Quality Management System (QMS); the complexity of the QMS will vary based on […]
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