Packaging Engineering

Our engineering services are turnkey packaging solutions that bundle specific services, performed by our experts, to get your product across the finish line.

Program Details

Who It's For

Any medical device manufacturer in the development process of a new product that requires sterile packaging.

Timeframe

Varies depending on the customization of the study.

What's Included

Panel Usability Evaluation
• Formalized Discussion Notes
• Photos and Panel Recommendations
• Objective evidence that the three items required by ISO 11607- 1:2019 have been evaluated
• Technical Summary Memo with Completed Evaluation Forms

Clinical Usability Evaluation
• Opportunity for study customization
• Technical immersion session to document device and packaging system to develop technical questions and acceptance criteria for the study
• Clinical assessor profile(s) with the user’s credentials, experience, demographics, and area(s) of expertise
• Complete details of the use environment, gowning, and surgical suite simulation
• Clinical use photographs of aseptic presentation techniques for the client’s products
• Video that captures the entire process of the clinical study
• Objective evidence that the three items required by ISO 11607- 1:2019 have been evaluated
• Protocol Report with moderator questionnaire, user responses, formal discussion notes, summary content and recommendations

Program Details

Who It's For

Any team in the design and development process of a new medical device that will require sterile packaging.

Timeframe

Typically, 4 to 6 weeks.

What's Included

  • Discovery session with your team
  • Product package assessment (PPA)
  • Two to four medical packaging design concepts
  • Quotes for materials/tooling and equipment to produce each
  • Functional prototypes where possible
  • Project plan and production schedule for each

Program Details

Who It's For

Any medical device company in the process of creating a new packaging design.

Timeframe

Typically, less than 1 week.

What's Included

  • Transit simulation testing
  • Visual inspection and sterile barrier integrity testing
  • Engineering test report, with findings and observations for all tests
  • Findings meeting with your team to review results and actionable recommendations

Program Details

Who It's For

Medical device manufacturers purchasing new sterile packaging equipment or in the process of validating a new packaging system.

Timeframe

Typically, 3 to 5 weeks.

What's Included

  • Authorship of protocols
  • Memorandum of seal characterization and range finding memo
  • Detailed work instructions for equipment and packaging
  • On-site client training
  • IQ/OQ/PQ validation reports
  • On-site equivalency validation

Program Details

Who It's For

Medical device companies facing a packaging failure in the distribution environment.

Timeframe

Typically, 3 to 5 weeks.

What's Included

  • Client conference to review the history of the packaging failure at issue
  • Fishbone diagram
  • Re-creation of failure through transit testing, if possible
  • Engineering analysis of potential factors and conclusions
  • Final report detailing root cause, additional findings and recommendations for path forward

Program Details

Who It's For

Companies with mature product lines facing potential regulatory gaps or remediation efforts.

Timeframe

Typically, 3 to 4 weeks.

What's Included

  • A thorough review of documentation records and previous validation testing protocols
  • On-site audit of the sterile packaging process
  • Comprehensive audit report of findings and actionable recommendations

Program Details

Who It's For

Any medical device manufacturer

Timeframe

Varies, based on your project

What's Included

Comprehensive sterile packaging support at any level

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