Sterilization Consulting Services

Ensuring regulatory compliance in a competitive market

  • Home
  • Sterilization
  • Microbiology
  • RA/QA
  • Packaging
  • Qualifications
  • Contact

RA/QA

Sterilization Consulting Services, also has expertise in quality systems. We have been involved in Quality Assurance for firms ranging in size from the startup to the multi-national. We recognize that the world of Medical Device manufacturing is under increasing regulatory pressure, coupled with an ever present need to reduce cost. Sterilization Consulting Services can assist on a project basis to handle a specific issues which does not result in the addition of staff.

RAQAw

Services provided include:

  • FDA and CE mark gap analysis, including pre-FDA auditing
  • Internal and Supplier auditing
  • Responses to FDA 483s and Warning letters
  • Assistance in System development or improvements
    • Customer Complaints
    • CAPA systems
    • FMEA
  • Evaluation and/or Development of Business Strategies

Qualifications

Experience: Harry Shaffer has over 33+ years experience in the sterilization and manufacturing of medical devices. In addition to expertise with radiation, EO and steam sterilization, Harry has also developed and validated sterilization cycles and procedures. Sterilization … Read More

Applicable Standards

AAMI/ISO standards detail the requirements and guidance used throughout the industry. These standards are consensus voluntary standards which are the minimum requirements for the manufacturing and sterilization of Medical Products. With a combination of these standards and the … Read More

Connect

Sterilization Consulting Services
Harry Shaffer
10051 Oak Leaf Way
Highlands Ranch, CO 80129
(303) 929-3808


hshaffer@sterilizationconsulting.com

Copyright © 2018 · Harry Shaffer · Designed by AVS Design Studio