Medical Device Quality Excellence

From Startup to Market Leader

Expert quality consulting for medical device companies navigating FDA compliance, ISO certification, and regulatory excellence.

CQA Certified CQE Certified Six Sigma Black Belt 20+ Years Experience
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Trusted by Leading Medical Device Companies

20+
Years Experience
50+
Companies Served
10+
Successful Exits
100%
Audit Success Rate

Problems We Solve

Comprehensive quality solutions for every stage of your journey

By Regulatory Process

FDA Compliance

  • 21 CFR 820 (QSR)
  • 510(k) submissions
  • PMA applications
  • IDE clinical trials

ISO Certification

  • ISO 13485 registration
  • CE Mark compliance
  • MDR/IVDR preparation
  • Notified Body audits

Design & Development

  • Design control processes
  • Risk management (ISO 14971)
  • Verification & validation
  • Design transfer

Manufacturing & Operations

  • Process validations
  • Cleanroom setup (ISO 14644)
  • Sterilization validation
  • Equipment qualification

Supplier Management

  • Supplier qualification
  • International supplier audits
  • Supplier CAPA management
  • Supply chain optimization

Quality Systems

  • CAPA system design
  • Document & records control
  • Internal audit programs
  • Management review processes

Software & AI/ML Compliance

  • IEC 62304 software lifecycle
  • Software as Medical Device (SaMD)
  • IEC 62366 usability engineering
  • Algorithm validation & verification
  • Cybersecurity (FDA guidance)
  • ISO 14971 software risk management
  • 21 CFR Part 11 electronic records

By Device Type

Cardiovascular

  • Aneurysm coils & delivery systems
  • Bare metal & drug-eluting stents
  • Guidewires & catheters
  • Embolic protection filters

Neurovascular

  • Embolic protection devices
  • Neurointerventional systems
  • Thrombectomy devices

Orthopedic/Spine

  • Vertebral body replacement
  • PMMA bone cements
  • Spinal implants

Women's Health

  • Permanent sterilization devices
  • Contraceptive systems

Ablation & Energy

  • Renal ablation systems
  • RF energy devices

Sensory Devices

  • Hearing aids
  • Implantable systems

Wearables & Digital Health

  • Continuous monitoring devices
  • Remote patient monitoring systems
  • Connected diagnostic devices
  • Therapeutic wearables
  • Mobile health applications

AI/ML-Enabled Devices

  • Diagnostic imaging AI (radiology, pathology)
  • Clinical decision support systems
  • Predictive analytics platforms
  • Computer-aided detection (CADe/CADx)
  • AI-powered screening tools
  • Adaptive treatment algorithms

By Company Stage

Early Stage Startup

Build a compliant quality system from the ground up. Strategic planning for FDA approval pathways and ISO certification readiness.

  • Quality system design & implementation
  • FDA strategy & pathway selection
  • Resource optimization
  • Design control framework

Growth Stage

Scale your operations while maintaining compliance. Navigate regulatory submissions and achieve certifications.

  • ISO 13485 certification
  • 510(k) & PMA submissions
  • Process validations
  • International market access

Established Company

Optimize existing systems, prepare for M&A, and maintain excellence through growth and change.

  • System optimization
  • Exit preparation & due diligence
  • Global expansion support
  • Continuous improvement programs

VC/PE M&A Due Diligence

Expert quality & regulatory assessment for investors and acquirers. Identify risks, validate compliance, and support deal valuation.

  • Quality system maturity assessment
  • FDA compliance status & risk analysis
  • Outstanding 483s, warning letters, recalls review
  • CAPA backlog & effectiveness evaluation
  • Supplier qualification & control adequacy
  • Post-market surveillance & complaint trending
  • Integration planning & synergy identification
  • Regulatory pathway & market clearance validation

Crisis Management

Rapid response to FDA warning letters, 483s, and consent decrees. Turn challenges into opportunities.

  • Warning letter response
  • 483 remediation
  • CAPA effectiveness
  • Audit readiness restoration
💡

"Father of the Infinity Design"

Kirk developed the foundational technology for the Boston Scientific FilterWire EZ, a market-leading embolic protection device launched in 2004. This innovation has helped protect thousands of patients during cardiovascular procedures.

Patent Holder Market Leader Proven Innovation

Our Team

Kirk Young, Founder & Principal

Led by Kirk Young, Founder & Principal

Young Partners brings together a network of seasoned quality and regulatory experts with deep experience across the medical device lifecycle. Led by Kirk Young, our team has established and maintained ISO/FDA compliant quality systems for innovative medical device companies for over 20+ years.

CQA - Certified Quality Auditor CQE - Certified Quality Engineer Six Sigma Black Belt MBA, Case Western Reserve BS Mechanical Engineering

What Sets Us Apart

  • Proven Track Record: Our team has been integral to multiple successful exits to Johnson & Johnson, Medtronic, Boston Scientific, and Covidien
  • Comprehensive Expertise: We cover the complete product lifecycle from design controls to distribution, with deep expertise at every stage
  • International Experience: Our network includes specialists in managing global suppliers and navigating international regulatory requirements
  • Innovation & Engineering: We bring patent holders and engineers with deep R&D backgrounds who provide technical insight to quality systems
  • Crisis Management: Our team specializes in rapidly addressing troubled quality processes with systematic, proven approaches
  • Strategic Focus: We enable strategic risk management for dynamic medical device companies, aligning quality with business objectives

Quality Leadership Experience

Our team has served as full-time and consulting resources in these companies:

Earlens
Shifamed / NuVera Medical
Shifamed / Maya Medical / Covidien
SpineAlign Medical
Palmaz Scientific (was J&J / NDC / re-established as Vactronix Scientific)
DFine
Cardiomind
Nitinol Devices & Components / Cordis / J&J
Conceptus
Sobek Medical / Embolic Protection / Boston Scientific
MedeonBio
Primal Therapies
Covidien / Barrx / Medtronic
PorOsteon
JSurgical
IncuMEDx Inc
Creganna-Tactx Medical
Codman Neuro / Johnson & Johnson
Ouroboros Medical
Shifamed / Bluegrass Vascular Technologies

What Colleagues Say

"

I had the pleasure of working very closely with Kirk Young when he was a Quality Manager at Palmaz Scientific. Kirk helped our company achieve quality objectives in a very short time frame in spite of very limited resources and numerous hurdles in his path. He is extremely knowledgeable and a tremendous team player.

Animesh Choubey, PhD Palmaz Scientific
"

Kirk came onboard as Quality Manager for DFine, Inc. while I was there as the Materials Manager. I found Kirk to be diligent in his work showing good attention to detail and concern for adhering to appropriate procedures. Kirk works well as a team member and communicates well across cross-functional teams.

Mike DeYoung DFine, Inc.
"

Kirk is a strong engineering leader who thinks 'out of the box' and is always on a quest for high quality solutions. He gets along well with just about everyone and is an excellent person to have on your team.

Alex Kitsis Industry Colleague