ISO 13485 Consultant Seattle Washington

Is your medical device company looking for an ISO 13485 consultant in Seattle Washington? Core Compliance has expertise within the Puget Sound region to provide guidance and ensure FDA regulatory compliance. Services include, evaluate and assess regulatory requirements associated with your medical device products and layout a road map to FDA compliance. 

ISO 13485:2016 is the international standard that specifies requirements for a quality management system (QMS) related to medical devices. CFR 21 Part 820 (Quality System Regulation QSR outlines Current Good Manufacturing) CGMP regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices.

ISO 13485:2016 Update

 Is your Seattle, WA based 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)

Regulatory Consulting Services 

Core Compliance provides regulatory consulting services for Seattle based medical devices manufacturing, distributor, supplier companies. Our consultants take the headache for companies looking to obtain ISO 13485:2016 certification, in developing a quality management system that meets FDA & ISO requirements. We build compliant medical device quality management systems that fits and benefits your organization, rather than just creating more documentation and work. 

Medical Device Consulting Services 

• Gap Analysis 
• Document Drafting
• CFR Part 820 Compliance
• GMP Good Manufacturing Practice
• 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 Schedule a consultation  

Regulatory Audit Services

Our local FDA consultants in the greater Seattle area provide audits 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