Medical Device Audit Compliance

Is your organization preparing for an upcoming medical device audit? Core Compliance ensures medical device audit compliance in providing the expertise to review and evaluate your device with applicable regulations.

We follow the best practices for auditing and monitoring the manufacturing of medical devices to International Medical Device Regulators Forum (IMDRF)

This program includes the relevant requirements of the regulatory authorities including the following countries-Australia, Brazil, Health Canada, Japan and the United States.

Medical Device Audit Services

CAPA management
Pre-Approval Inspections (PAI)
Multi-Country Registration & Approval
510k CE Mark compliance
GxP Audits
FDA Mock Inspections
ISO Compliance ISO 13485 ISO 9001 ISO 14971
Internal Audits
Validation Computer Systems Audit
MDD/IVDD/AIMDD Compliance Audits
GMP, GLP and GCP environments and state-of readiness assessments

Receive an initial health check of your products, systems and manage systems to meet regulatory requirements with a clear road map to maintain compliance.

Audit Submission Registration Approval Process

Core Compliance provides services to audit submission registration approval process to ensure compliance. We assist all types of companies requiring regulatory compliance for products & systems to Multi-Country Registration and Approvals in assessing regulatory compliance & regulations. No need to hire a full-time employee to manage all of the regulatory requirements, our regulatory consultants give your organization the flexibility for Ad-Hoc hourly basis or retain them for a set amount of hours monthly.

FDA Regulatory Audit Submissions Registration Approval Services

Multi- Country Registration & Approvals US 510K EU CE Mark Health Canada MDL
Independent review Product Submissions/Compliance
Technical File review EU
CE Mark Compliance Assessments
New Product development process
FDA Regulatory compliance road map

MDSAP Medical Device Audit

Looking to become compliant with MDSAP requirements? Core Compliance provides consulting services.

Training
Gap Analysis- (Audit checklist)
Pre-inspection Audits
Evaluate process controls, records and document control systems for compliance
Compliance of contract services providers
Supplier Audit review

Regulatory Audit Services

Core Compliance provides FDA experienced auditors that provide regulatory audit services to ensure a quality system that 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.

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