External Audit Services Medical Devices
External Audit Services Medical Devices
Do you have a pending FDA Audit to prepare for and would like an experienced FDA regulatory consultant to evaluate current state, prepare and train your organization? Core Compliance provides external audit services for medical devices, facilities, suppliers and contract manufacturing organizations. Stay compliant to international regulatory requirements, mitigate risk with contract facilities and maintain suppliers.
Receive an initial health check of your products, systems, and manage systems to meet regulatory requirements with a clear road map to maintain FDA compliance. We have expertise in the following industries, Medical Devices, Pharmaceutical and In-Vitro Diagnostics.
Regulatory External Audit Services
Core Compliance provides regulatory external audit services, to provide external audit options to medical device organizations. Contract manufacturing, laboratories, suppliers
Maintain FDA Regulatory compliance
- 21 CFR part 820
- 21 CFR part 11
- 21 CFR part 211
- 21 CFR part 212
- Good Manufacturing Practices (GMP)
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
ISO Compliance
- ISO 9001:2015 Quality Management System
- ISO 13485:2015 Medical Devices
- ISO 14971 Risk Management
Regulatory FDA Mock Inspections
Looking to get a regulatory FDA mock inspection for GMP, GLP and GCP environments and state-of readiness assessments? Core Compliance provides (Quality System Regulation) mock audits to help prepare for an FDA inspection to ensure compliance with our experienced consulting experts. Get the peace of mind knowing you will be prepared for an upcoming FDA audit.
Our FDA Consultants set a pre-determined date with total days to start the process at your facilities, with a clear agenda for compliance. We review your production facilities, utilities, validation, testing and other manufacturing documentation, in creating a road map and training.
- Regulatory FDA Document review and preparation
- Pre-inspection Audits
- Evaluate process controls, records and document control systems for compliance
- Compliance of contract services providers
- Supplier Audit review
ISO Compliance Services
Our Regulatory consultants provide comprehensive ISO compliance services to review of your current quality management system to ensure your organization is current to ISO 9001:2015 & ISO 13485:2016.The ISO certification process is a key aspect on the road map for FDA compliance. Core Compliance consultants specialize in reviewing or developing a Quality Management System that represents your Medical Device organization internal business processes and procedures and incorporating necessary requirements for compliance with ISO 9001 ISO 13485 standards.
External Audit Services
We have FDA experienced auditors for your quality system yields benefits beyond meeting FDA requirements. It assures that your quality system is providing the information you need to manage product quality, personnel performance, and production efficiency – information essential to business success.
FDA Audits performed include:
- CAPA handling and closure
- CE Mark Compliance Assessments
- Complaint handling
- Compliance audits, assessments, and gap analyses
- Compliance Engineering Support
- Computer systems audits and Part 11 assessments and remediation
- Comprehensive remediation strategies
- Due Diligence and Compliance Audits, Assessments and Remediation Strategies
- FDA mock inspections for GMP, GLP and GCP environments and state-of readiness assessments
- Gxp Audits
- ISO 13485/ISO 9001
- Medical device audits for 21 CFR Parts 820 (QSR and QSIT audits)
- MDD/IVDD/AIMDD Compliance Audits
- Mock FDA GxP inspections
- Mock Pre-Approval Inspection (PAI)
- Multi-Country Registration and Approvals
- Preparation of responses to FDA 483, citations, and warning letters
- Quality System/GMP Audits using FDA QSIT Techniques
- Routine internal audits
- Software Quality Assurance and SW V&V Auditing
- Strategic GxP Compliance Consulting: GCP, GLP, GCP
- Supplier QA audits
- Supply-chain audits
- Validation audits Start the process
ISO Standards
Core Compliance has expertise in the following ISO standards:
ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID –Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001– Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems
External Audit Services Medical Devices
In the highly regulated world of medical devices, ensuring regulatory compliance and maintaining high-quality standards is paramount. External audit services medical devices play an essential role in achieving these goals, offering an objective evaluation of company processes and products.
What Are External Audit Services for Medical Devices?
External audit services involve assessments conducted by independent third-party auditors who evaluate a company’s adherence to industry-specific regulations and standards. For medical device manufacturers, these audits are crucial to ensure their quality management systems (QMS) and products meet the legal and regulatory frameworks, such as ISO 13485, the FDA’s Quality System Regulation (QSR), and the EU’s Medical Device Regulation (MDR).
Types of External Audits in the Medical Device Industry
There are several audit types that fall under external audit services for medical devices:
- Quality Management System (QMS) Audits: These audits evaluate a company’s QMS, ensuring it meets the necessary standards for managing quality throughout the product lifecycle. A robust QMS is vital for maintaining consistent product quality and minimizing risks.
- Product Audits: These audits focus on individual medical devices, verifying they meet safety and performance standards. Product audits are critical for ensuring devices comply with design specifications and regulatory requirements.
- Supplier Audits: These audits assess the quality and reliability of suppliers, ensuring that all materials and components used in medical devices meet the required standards.
- Process Audits: These audits evaluate specific processes within a company, ensuring they are efficient and comply with regulatory guidelines. Process audits help identify areas for improvement and optimize manufacturing and quality assurance processes.
Importance of External Audit Services Medical Devices
External audit services medical devices are indispensable for several reasons:
- Regulatory Compliance: These services provide an unbiased assessment of a company’s compliance with applicable regulations, reducing the risk of non-compliance and legal issues.
- Quality Assurance: Independent audits ensure that a company’s quality management practices are effective, crucial for maintaining high product standards and minimizing risks.
- Risk Management: By identifying potential issues before they escalate, audits help companies manage risks associated with product safety and regulatory compliance.
- Continuous Improvement: Audit findings can guide companies in enhancing their processes, leading to greater efficiency and effectiveness in operations.
Benefits of External Audit Services for Medical Devices
Utilizing external audit services offers several advantages for medical device companies:
- Objectivity: External auditors provide an impartial perspective on a company’s processes and compliance, crucial for identifying strengths and weaknesses.
- Expertise: External auditors bring specialized knowledge of industry regulations and standards, assisting companies in navigating complex compliance landscapes.
- Credibility: An independent validation of company compliance can enhance reputation and build trust with stakeholders, including regulatory bodies and customers.
- Resource Efficiency: By outsourcing audit activities, companies can focus internal resources on core business operations while ensuring compliance is maintained.
Conclusion
External audit services for medical devices are a cornerstone of regulatory compliance and quality assurance. By providing independent evaluations and expert insights, these audits help companies meet regulatory standards, improve product quality, and ensure the safety and effectiveness of their medical devices.
