Utah Professional Regulatory Services

Our local consultants provide Utah professional regulatory services that are comprehensive FDA and clinical consulting services for small companies, start-ups and for larger companies, including virtual companies attempting to get their medical device through the regulatory process.

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.Learn more Regulatory Services

Submission Management

  Core Compliance provides FDA submission management with giving your Utah based company guidance for all-electronic submissions to the FDA and international regulatory requirements. With 20 years of experience in clinical research, product development, data standards, quality assurance, and regulatory affairs, our consultants streamline product approval and gain a competitive advantage!

Product/Device Regulatory Classifications

United States Food and Drug Administration (FDA) has 3 medical device classes: Class I, II, and III. Classification is based on the medical application and the potential risk associated with your product.

European Union (EU) MDD 93/42/EEC has 4 medical device classes Class I, IIa, IIb, and III

Canada- Health Canada- 4 device classifications–Class I, II, III and IV– Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282

Product/Device Regulatory Management

We manage product/device regulatory requirements for your products,

• Initial determination & classification
• Create road map to FDA compliance, obtain CE Mark, 510k pre-market notification & regulatory clearance  
• Identify what nations products will need compliance and requirements involved United States, Europe, Canada
• Quality/Risk Management System for ISO requirements & 21-CFR-820 GMP 
  • ISO 13485, ISO 9001, ISO 14971 
• Fulfill requirements & prepare and maintain technical file
• Perform Risk Analysis on products 
• Compliance with Labeling requirements (Review current marketing materials, and manual developed for users information to ensure compliance)
• Prepare Declaration of Conformity & supporting evidence
• Testing product Safety & Performance
• Arrange meeting with applicable representative European Union (EU) United States 510k submission, Health Canada
• Identify notifying body

The process will be different depending on regulatory requirements relative to the medical application, technology, and national regulations.

Utah Regulatory Audit Services

We provide Utah regulatory audit services with experienced auditors located here in Utah to consult your Medical Device organization in building 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

Core Compliance provides Utah GMP compliance services. 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 local Utah based consulting with extensive FDA experience in guiding Medical Device, Pharmaceutical companies a clear road to GMP cGMP FDA compliance. Start GMP Compliance

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 to ISO 13485 & FDA Compliance

Road map to ISO 13485:2016 & FDA compliance,

Preparation Core Compliance educate med-device pharmaceuticals companies on expectations for ISO 13485 requirements FDA/cGMP 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 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

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.