Welcome to Shriner & Associates Inc.

Simplifying Medical Device Quality Assurance and Regulatory Affairs

Having helped thousands of Medical Device, and Combination Product companies with Quality Assurance and Regulatory Affairs challenges, Shriner & Associates has the expertise to help you navigate the global regulatory landscape.  From building a full Quality System to resolving issues with Regulatory bodies, we are the right choice for your QA/RA issues.

 

Who We Are

Device Industry Professionals

At Shriner & Associates Inc., we've been helping clients navigate the regulatory environment in Medical Devices since the mid 1990's.  Our founders and principle consultants have decades of experience with all types of medical devices from implants to particle accelerators.


If your business needs specialized expertise from resources that have helped thousands of others successful introduce new products and cure their regulatory issues, call us.  We completely guarantee all our services and deliverables. 


Trust your quality and regulatory issues to resources with an unsurpassed history of success and a reputation for the highest quality of service and expertise. 


Our team of experts is ready to help you develop and implement strategies for not only surviving, but thriving in this complex, highly regulated environment. Give us a call today to set up your first consultation.

Working Together
 

Products and Services

With more than 3 decades of experience in the Medical Device Industry, our consultants have the experience and expertise to address all your Quality Assurance, Regulatory Affairs and Compliance needs. From building a compliant QMS from scratch to solving complex submission issues, Shriner & Associates has the right solution.

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Quality Management Systems

  • Development, Training and Implementation

  • Selection of QMS Automation Tools

  • Outsourcing Services

  • 3rd Party / Independent Audits

  • Regulatory Audit Support

  • 483 and Warning Letter Responses

  • Global Planning

Global Regulatory Affairs and Submissions

  • Route-To-Market Strategic Planning

  • Submission Planning

  • Regulatory Body Communication

  • Bench and Trial Planning and Execution

  • Identification of Applicable Requirements

  • Submission Creation and Official Correspondent

  • Advocacy

Special Services and Unique Expertise

  • Quality Systems for Software Products (SaMD)

  • QMS Right-Sizing

  • Remediation

  • Software Verification and Validation

  • Software Development Lifecycles and Mapping Agile Processes to Design Controls

  • Unique Validation Services (Cleaning, Sterilization, Packaging)

  • Combination Products

  • Human Factors and Usability

 
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Contact Us

429 Whitepine Creek Rd

Trout Creek, Montana 59874

USA

OFFICE: +1.406.827.3541

MOBILE +1.303.907.2955

 

OFFICE: +1.406.827.3541

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