Utah FDA Consultants

Core Compliance is located in the Salt Lake City, Utah market. We have local FDA consultants that specialize in identifying a clear plan for FDA compliance and ISO Certification. Some of the FDA Services our consultants provide,

• FDA Regulatory Road Map
• FDA Submissions management CE Mark, 510k, Health Canada
• FDA Auditing
• Quality Management Systems development -ISO 13485 ISO 9001

Contact Core Compliance to schedule a local Utah based FDA consultant for an onsite visit today. FDA Consultant onsite evaluation

Utah Regulatory Services

Our Regulatory consultants are located here in Utah provide comprehensive regulatory and clinical services for all types of companies, start-ups and for larger companies. We can do virtual companies attempting to get their medical device through the regulatory process. We provide virtual webinar training for any location.

Our expertise with FDA requirements in the following industries, Medical Devices, Pharmaceutical and In-Vitro Diagnostics to provide a clear road map for your organization regulatory needs.

Utah FDA Submission Management

Core Compliance provides FDA Submission Management for Utah based Medical Device, Pharmaceuticals, Nutraceutical companies for pre-market submission.Our FDA consultants manage the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance. FDA Submission Management area,

• USA Pre-market notification- 510k submission
• Canada– Health Canada Medical Device License (MDL) (MDEL) (MDALL)
• Europe– CE Marking

Core Compliance FDA consulting experts start the process with your Utah Company today- Get a quote  

Utah Regulatory Audit Services

We have FDA experienced auditors located in Utah 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

Utah GMP Compliance

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Core Compliance has extensive FDA experience in guiding Medical Device, Pharmaceutical companies a clear road to GMP cGMP FDA compliance. Learn More

cGMP regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. See facts about good manufacturing practices- Learn More

Road Map for ISO 13485 Certification 

ISO 13485:2016 certification is a two-part process,

Step1

Preparation Core Compliance educate med-device companies on expectations for ISO 13485 requirements FDA compliance a layout the road map with objectives and milestones. We work with designated management Representatives, for and educational training approach to be taken, for buy-in from company employees. We coordinate with the ISO 13485 QMS road map with designated representatives through online webinars and/or onsite F2F consultation.

Discovery-Gathering current related QMS documentation onsite related to ISO 13485 requirements, along with providing QM, QP QO’s, procedures, work instructions, forms/exhibits.

Gap Analysis current state of Quality Management Systems compared to ISO 13485 requirements. Update road map based upon findings for clear next steps and milestones for ISO 13485 certification. On completion of approved QMS, we move to implementation.

Implementation/Training- of QMS system with company and provide onsite or webinar training. 

Internal Audit- education and training with a mock-audit for preparation with staff for Registrar Audit

Step 2

A certification body, also referred to as a “registrar”, performs an audit to assess compliance with the standard and the organization’s declared management system. Upon a successful audit, the organization is granted a certificate of compliance from the trusted third party registrar. The organization undergoes additional but lesser surveillance audits at least annually thereafter for 3 years until the certification then expires and requires a re-certification.

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

Salt Lake City Service Area ISO Consulting

We cover the entire state of Utah for ISO certification services

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