Packaging Compliance Labs
Packaging Compliance Labs is a leading provider of sterile medical device packaging testing, contract packaging, and engineering services. Established in 2014, the company is committed to delivering solutions that enable life-changing medical innovation. With certifications including ISO 17025, ISO 13485, and ISTA, PCL partners with medical device manufacturers across the United States and internationally to ensure product safety, compliance, and efficient market entry. The company also offers extensive testing capabilities including ASTM D4169 transit simulation, environmental conditioning, high-altitude testing, and more, to ensure packaging durability and safety in various conditions.
Industries
Nr. of Employees
small (1-50)
Products
Package Testing
Conducts ISO 11607 sterile package testing for medical devices, including transit/distribution simulations, shelf life, and sterile barrier integrity tests.
Contract Packaging
Offers ISO 13485 certified contract packaging services for low to medium-volume projects, including labeling, packaging, precision cleaning, sterilization validation, and sterile product management.
Packaging Engineering
Provides concept-to-validation packaging engineering services to ensure compliance with ISO 11607 for terminally sterilized medical device packaging.
CompliancePack™
An expedited packaging solution compliant with ISO 11607, offering pre-validated packaging options like Tyvek peel pouches and trays to accelerate device launch.
Sterilization Validation & Sterile Product Management
Manages sterilization validation processes and partners with third-party providers to ensure proper sterilization using Gamma, EO, and EBeam methods.
Package Testing
Conducts ISO 11607 sterile package testing for medical devices, including transit/distribution simulations, shelf life, and sterile barrier integrity tests.
Contract Packaging
Offers ISO 13485 certified contract packaging services for low to medium-volume projects, including labeling, packaging, precision cleaning, sterilization validation, and sterile product management.
Packaging Engineering
Provides concept-to-validation packaging engineering services to ensure compliance with ISO 11607 for terminally sterilized medical device packaging.
CompliancePack™
An expedited packaging solution compliant with ISO 11607, offering pre-validated packaging options like Tyvek peel pouches and trays to accelerate device launch.
Sterilization Validation & Sterile Product Management
Manages sterilization validation processes and partners with third-party providers to ensure proper sterilization using Gamma, EO, and EBeam methods.
Services
Accredited laboratory testing for medical device packaging, including environmental conditioning, transit/distribution simulation (drop, compression, vibration, flight profiles), integrity testing (dye, Gelbo), and high-altitude vacuum-chamber simulations aligned to ISO 11607, ASTM and ISTA standards.
Contract packaging and assembly services for sterile medical devices provided in an ISO 13485-certified facility, covering precision cleaning, sealing, labeling and sterilization-validation support for low- to mid-volume production.
Packaging engineering services including design concepts, feasibility/proof-of-concept testing, usability/human-factors evaluations, sealer validation development, test method validation and packaging optimization to support launch readiness.
Monitoring and interpretation of consensus standard revisions, participation in standards committees, and implementation support including SOP updates, retraining and re-validation to maintain regulatory and standards compliance.
Accredited laboratory testing for medical device packaging, including environmental conditioning, transit/distribution simulation (drop, compression, vibration, flight profiles), integrity testing (dye, Gelbo), and high-altitude vacuum-chamber simulations aligned to ISO 11607, ASTM and ISTA standards.
Contract packaging and assembly services for sterile medical devices provided in an ISO 13485-certified facility, covering precision cleaning, sealing, labeling and sterilization-validation support for low- to mid-volume production.
Packaging engineering services including design concepts, feasibility/proof-of-concept testing, usability/human-factors evaluations, sealer validation development, test method validation and packaging optimization to support launch readiness.
Monitoring and interpretation of consensus standard revisions, participation in standards committees, and implementation support including SOP updates, retraining and re-validation to maintain regulatory and standards compliance.
Expertise Areas
- Medical device packaging engineering
- Sterile barrier system validation and integrity testing
- Transit and distribution simulation testing (ASTM D4169, ISTA)
- Contract sterile-device packaging and assembly (ISO 13485 environments)
Key Technologies
- ASTM D4169 transit/distribution simulation
- ISTA series transit testing
- Environmental preconditioning and conditioning chambers
- Vacuum-chamber high-altitude/pressure-differential simulation
News & Updates
Packaging Compliance Labs Completes Acquisition of Quest Engineering Solutions, Expanding Testing Capabilities and East Coast Presence. Grand Rapids, MI, May 13, 2025.
Industry event held in Boston, MA on September 19, 2024.
Industry event held in Chicago, IL from November 3-6, 2024.
National Association of Surgical Supplies event in Chicago, IL, September 25-28, 2024.
Event in Houston, TX on November 19-20, 2024.
Event in Denver, CO on October 31-November 1, 2024.
Packaging Compliance Labs Completes Acquisition of Quest Engineering Solutions, Expanding Testing Capabilities and East Coast Presence. Grand Rapids, MI, May 13, 2025.
Industry event held in Boston, MA on September 19, 2024.
Industry event held in Chicago, IL from November 3-6, 2024.
National Association of Surgical Supplies event in Chicago, IL, September 25-28, 2024.
Event in Houston, TX on November 19-20, 2024.
Event in Denver, CO on October 31-November 1, 2024.