Packaging Compliance Labs

What Packaging Compliance Labs does

Packaging Compliance Labs (PCL) is a privately held medical device packaging services provider founded in 2014 and headquartered in Kentwood, Michigan, with additional lab facilities in Grand Rapids, MI and Billerica, MA (PCL East). The company serves medical device manufacturers, pharmaceutical companies, and early-stage device startups with three integrated service lines: ISO 17025-accredited package testing (transit simulation per ASTM D4169/ISTA, accelerated and real-time aging per ASTM F1980, sterile barrier integrity testing, material and label testing, pharmaceutical CCIT, cold chain per ISTA 7D/7E, MVTR, ICH stability, and device vibration/shock/IP testing); packaging engineering (usability evaluation in simulated surgical suites, packaging design concept, feasibility/proof of design, turnkey sealer validation, root cause analysis, and test method validation); and ISO 13485-certified contract packaging in a Class 7 cleanroom, including sterile packaging, kitting, assembly, sterilization validation, precision cleaning, and the proprietary CompliancePack (CPack) pre-validated packaging platform. PCL holds ISO 17025, ISO 13485:2016, ISTA, FDA Registered, and A2LA credentials, and is backed by SV Health Investors following a June 2023 private equity partnership that funded the May 2025 acquisition of Quest Engineering Solutions.

Revenue is generated on a custom, project-based, fee-for-service pricing model across all three service lines, with no minimum volume requirements on contract packaging and a stated 24-hour dock-to-start and 48-hour report turnaround commitment. Go-to-market relies on direct enterprise field sales led by Senior Sales Engineers, inside sales engineers handling inbound Request-a-Quote inquiries, and event-driven demand generation through five consecutive years of [PACK]out conference sponsorship, HealthPack participation, Lunch and Learns, technical webinars, and content marketing via a technical blog, monthly newsletter, LinkedIn presence, and trade publication features. Notable customers cited publicly include Coloplast (usability evaluation for aseptic presentation), OrthoPediatrics (non-sterile to sterile packaging transition), and PherDal (sterile contract packaging for a fertility device). The company has appeared on the Inc. 5000 list for three consecutive years and won Best and Brightest Companies to Work For recognition at national and regional levels in 2023 and 2024, reflecting a workforce of 11-50 employees organized under a CEO (Matthew Lapham, co-founder), CFO (Don Kring, since March 2024), and Chief Commercial Officer (Jenn Goff, since January 2025).

Name

Packaging Compliance Labs

Legal name

Packaging Compliance Labs, LLC

Website

https://pkgcompliance.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Packaging Compliance Labs is a privately held, ISO 17025/13485-accredited medical device packaging services provider offering integrated package testing, packaging engineering, and ISO 13485 contract packaging (including the CompliancePack pre-validated platform) to medical device manufacturers, pharmaceutical companies, and device startups across the US.

Ownership category

akta.pro rank

Product category

Medical Device Packaging Services

NAICS

Testing Laboratories and Services (541380), Packaging and Labeling Services (561910)

SIC

Services-Testing Laboratories (8734), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Medical & Pharmaceutical Thermoformed Packaging (IMANAHAB)

akta.pro secondary industry

Sustainability Testing, Certification & Compliance (LCA, Recyclability/Compostability Testing, FSC/PEFC) (IMALAMAK)

Keywords

• Medical device packaging
• Sterile barrier testing
• Package validation services
• Contract packaging services
• ISO 11607 compliance

Headquarters

HQ city

Kentwood

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Package Testing Services: ISO 17025-accredited testing services including transit testing (ASTM D4169, ISTA series), shelf-life testing (accelerated aging ASTM F1980, real-time aging), sterile barrier integrity testing, and material/label testing. Revenue is generated on a per-project, fee-for-service basis.
2. Packaging Engineering Services: In-house engineering support including usability evaluations, packaging design concept, feasibility testing, turnkey sealer validation, root cause analysis, and test method validation. Billed as project-based consulting engagements.
3. Contract Packaging Services: ISO 13485-certified contract packaging including CompliancePack pre-validated packaging, sterile product packaging, sterilization validation, precision cleaning, kitting, assembly, and labeling. Revenue is project/volume-based with no minimum requirements.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

Packaging Compliance Labs provides ISO 17025-accredited medical device packaging testing, packaging engineering, and ISO 13485-certified contract packaging services to medical device and pharmaceutical manufacturers. The company helps clients comply with ISO 11607 by offering transit testing, shelf-life testing, sterile barrier integrity testing, usability evaluations, packaging design, sealer validation, and sterile product packaging in a Class 7 cleanroom, all under one integrated service model.

Product overview

Packaging Compliance Labs (PCL) operates as a comprehensive medical device packaging platform organized around three interconnected service lines: Package Testing, Packaging Engineering, and Contract Packaging. The Package Testing line encompasses transit testing (ASTM D4169/ISTA), shelf-life testing (accelerated/real-time aging), sterile barrier integrity testing, and material/label testing. The Packaging Engineering line provides concept-to-validation support including usability evaluation, packaging design concept, feasibility testing, turnkey sealer validation, root cause analysis, and test method validation. The Contract Packaging line — certified to ISO 13485 — offers sterile packaging in a Class 7 cleanroom and includes the pre-validated CompliancePack (CPack) platform, sterilization validation, and precision cleaning. PCL also offers pharmaceutical testing (CCIT, cold chain, MVTR, ICH stability) and device testing (vibration, shock, ingress protection, altitude). The portfolio is unified by shared ISO 17025 accreditation, in-house engineering expertise, and a one-stop-shop model that allows clients to move from concept through validation to contract packaging with a single partner.

Differentiator

Problem solved

Functional benefit

Brands

• CompliancePack™ (CPack): PCL's ISO 11607-compliant pre-validated packaging solution for medical devices, available in tray and pouch configurations.

Products and services

• Package Testing Comprehensive ISO 17025-accredited package testing services for medical device packaging compliance with ISO 11607, including transit simulation, shelf-life testing, sterile barrier integrity testing, and material/label testing for medical device manufacturers.
• Pharmaceutical Testing

Quantifiable outcome

• 24-hour dock to start time
• +4 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Quest Engineering SolutionscoreStrategic or Co-development Partner · 1 May 2025Quest Engineering Solutions was acquired by PCL in May 2025, becoming PCL East. Founded in 1995 and based in Billerica, MA, Quest was an ISO 17025-accredited testing laboratory specializing in mechanical testing services including package testing, medical package integrity testing, and product testing. The acquisition expanded PCL's geographic reach to the East Coast and broadened testing capabilities to include product testing and new test methods. Quest President Herman Held joined PCL along with the talented team.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Nelson Labs: Nelson Labs is the most direct competitor to PCL — an ISO 17025-accredited testing laboratory specializing in medical device, pharmaceutical, and tissue package validation (sterile barrier integrity, accelerated aging, transit, CCIT). It serves the same medical device OEMs and runs a contract testing/consulting model highly analogous to PCL's testing line.
• Eurofins Medical Device Testing: Eurofins Medical Device Testing provides ISO 17025 package validation, ISO 11607 compliance, sterile barrier integrity, accelerated aging, and transit testing for medical device manufacturers globally. It competes head-to-head with PCL's Package Testing line, particularly on large enterprise accounts needing multi-region capacity.
• Steripack Group: Steripack is an ISO 13485-certified contract packaging provider serving medical device and pharmaceutical OEMs with sterile barrier packaging, kitting, assembly, and sterilization management — a near-identical match to PCL's Contract Packaging line including its pre-validated packaging offering.
• Eurofins BioPharma Product Testing: Eurofins' BioPharma Product Testing arm delivers ICH stability, cold chain, MVTR, and CCIT services for pharmaceutical packaging — directly overlapping PCL's Pharmaceutical Testing line and serving the same pharma manufacturers needing ISO 17025-accredited package validation.

Broad incumbents

• WuXi AppTec Medical Device Testing: WuXi AppTec offers medical device biocompatibility, sterilization, and package validation testing as part of a broader CRO/CDMO portfolio. It serves overlapping medical device customers but as one capability among many rather than as a specialized packaging-focused lab.
• Intertek: Intertek is a global TIC (testing, inspection, certification) incumbent with medical device packaging testing, transit simulation, ISTA certification, and ISO 11607 consulting. It competes for enterprise-level package testing programs but does not specialize in the medical packaging niche the way PCL does.
• SGS: SGS provides medical device package testing, sterilization validation, and ISO 11607 compliance services as part of a global testing/inspection network. It is a broad incumbent competing on scale and accreditation breadth rather than the integrated testing-plus-contract-packaging model PCL offers.
• Element Materials Testing: Element provides ISO 17025-accredited package, product, and environmental testing for medical device and pharmaceutical clients. It competes with PCL on lab testing services and recently acquired medical testing businesses, but lacks the integrated ISO 13485 contract packaging arm PCL operates.

Regional players

• Medical Packaging Inc. (MPI): MPI is a US-based ISO 13485 contract packager providing sterile barrier packaging, kitting, and assembly for medical device OEMs. It directly competes with PCL's Contract Packaging line for low-to-medium-volume medical device production work, though its geographic footprint skews differently.

Emerging players

• Curia (formerly AMRI): Curia provides sterile fill-finish and contract manufacturing with adjacent packaging validation and testing capabilities for injectable drugs and biologics. It is an emerging player overlapping PCL's pharmaceutical cold-chain and CCIT services for biologics-focused customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights8 records

Customer concentration

• LinkedInlinkedin.com/company/pkgcompliance
• Facebookfacebook.com/timeline

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Packaging Compliance Labs