ISO 13485 Certification in California

Is your organization looking receive ISO 13485 certification in California? ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) related to medical devices. Core Compliance has local consulting expertise with California based medical device companies in guiding them to ISO 13485:2016 compliance.This standard outlines the requirements related to quality management for an organizations’ need to demonstrate its ability to provide medical devices and related services that consistently meet customer’s and regulatory FDA requirements.

ISO 13485:2016 Update

 Is your California Medical Device organization looking to transition to ISO 13485:2016 update? This is the most recent development since 2003 & there are important reasons to stay in compliance in keeping up with changes in the industry. You have until January 1st 2019 to transition your current QMS to the ISO 13485:2016 update.

Core Compliance consultants have 30 years experience in the medical device industry with straight forward approach in implementing requirements with the changes to ISO 13485:2016.

Key changes to ISO 13485:2016 to align with your current QMS:

• QMS Aligns with Regulations, Framework
• Design Controls & Risk Management
• Aligned with FDA regulations to FDA 21 CFR Part 820  (See requirements CFR – Code of Federal Regulations Title 21)

ISO 13485:2016 Consulting Services California

Core Compliance provides ISO 13485:2016 consulting services for California medical devices manufacturing companies. Our consultants take the headache for companies looking to obtain ISO 13485 Certification, in developing a quality management system that meets FDA & ISO requirements. We build a custom QMS that fits and benefits your organization, rather than just creating more documentation and work. 

Consulting Services include:

• Current state of compliance (Evaluation Gap Analysis) QMS- Medical Device Products- Risk Assessment 
• CFR 821 Compliance
• Product ID Management
• Process and Product Verification & Validation
•  ISO 13485 Internal Auditor Training and Certification

Core Compliance can help you achieve ISO 13485 certification in as little as 60-90 days

Regulatory 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