Packaging Compliance Labs
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.
- Company typePrivate
- Founded2014
- HeadquartersKentwood, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
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).
Packaging Compliance Labs firmographics
Firmographics- 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
Packaging Compliance Labs industry classification
Industry- 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
Where Packaging Compliance Labs is headquartered
LocationHeadquarters
- HQ city
- Kentwood
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Packaging Compliance Labs business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- 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.
- 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.
- 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
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Custom project-based pricing |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels7 records
Packaging Compliance Labs product offering
Product offeringCore 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
Companies that use Packaging Compliance Labs
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles3 records
Packaging Compliance Labs technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Packaging Compliance Labs partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Quest Engineering SolutionscoreQuest 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
Packaging Compliance Labs competitors and assessment
Company assessmentDirect 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
Packaging Compliance Labs social profiles
Digital presencePackaging Compliance Labs compliance and trust
Trust signalCompliance5 records
Packaging Compliance Labs financial estimates
Financial estimateRevenue estimate
Valuation estimate
Packaging Compliance Labs leadership team
Management profileNumber of profiles
Profiles8 records
Packaging Compliance Labs subsidiaries and ownership
Company hierarchySubsidiaries1 record
Packaging Compliance Labs funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Packaging Compliance Labs M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Packaging Compliance Labs
What does Packaging Compliance Labs do?
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.
Is Packaging Compliance Labs a public or private company?
Packaging Compliance Labs is a private company. It is classified as private equity controlled and is currently operating.
When was Packaging Compliance Labs founded?
Packaging Compliance Labs was founded in 2014. It employs 11 to 50 people.
Where is Packaging Compliance Labs based?
Packaging Compliance Labs is headquartered in Kentwood, United States, in the North America region.
How does Packaging Compliance Labs make money?
Three revenue lines are on record. Package Testing Services are the primary driver. The others are packaging Engineering Services and contract Packaging Services.
Who are Packaging Compliance Labs's main competitors?
Direct peers on record are Nelson Labs, Eurofins Medical Device Testing, Steripack Group and Eurofins BioPharma Product Testing. Broad incumbents are WuXi AppTec Medical Device Testing, Intertek, SGS and Element Materials Testing. Medical Packaging Inc. (MPI) is listed as a regional player. Curia (formerly AMRI) is listed as an emerging player.
Does Packaging Compliance Labs have an API?
No public API is recorded for Packaging Compliance Labs.
What industry is Packaging Compliance Labs in?
Packaging Compliance Labs's product category is Medical Device Packaging Services. Its primary akta.pro industry code is IMANAHAB, Medical & Pharmaceutical Thermoformed Packaging, with a secondary code of IMALAMAK, Sustainability Testing, Certification & Compliance (LCA, Recyclability/Compostability Testing, FSC/PEFC). Its NAICS code is 541380 and its SIC code is 8734.