Fractional Services

Expert quality and operational support tailored to your startup’s stage and needs, complete with QMS implementation and document control included.

Everything You Need, Nothing You Don’t

We provide flexible fractional quality and operational support across the entire product development lifecycle. Unlike traditional consulting, you get a complete package: QMS implementation, document control system, and access to our partner network, all included.

Complete Package

No separate QMS or document control fees. Everything you need is included in your monthly service.

Priority-Driven

We focus your hours on the highest-impact work, adapting to your development roadmap each month.

Expert Network Access

Connect with vetted biocompatibility consultants, sourcing managers, and other specialists as needed.

Scale Your Support

Essential

5-10 hours/week

Perfect for early-stage teams needing early quality oversight and strategic guidance.

✓ Quality approval authority
✓ Document review and release
✓ Risk management support
✓ Strategic advisory as needed
✓ QMS implementation included
✓ Document control system included

Strategic Value:

  • The infrastructure you need to get started plus a sounding board for direction-setting and critical thinking
  • Keeps your team on track without heavy time investment

Growth

15 hours/week

Ideal for companies scaling up with active design controls and supplier management needs.

All Essential features, plus:

✓ Guide deliverables and design reviews

✓ Supplier qualification and support

✓ Failure analysis & root cause investigations

✓ Training and knowledge building

✓ Expanded advisory capacity

Strategic Value:

  • A consistent partner moving program forward
  • Adds confidence, brings perspective, and increases speed of execution

All-In

It’s handled

Full accountability without hourly restrictions. Quality & operational functions, handled completely.

All Growth features, plus:

✓ Unlimited hours as needed

✓ Full Quality leadership accountability

✓ Strategic operational planning & execution

✓ FDA and issue response capacity

✓ Comprehensive audit prep

Strategic Value:

  • Accountable partner in your ops
  • Contributor delivering on your roadmap
  • Amplifies capacity without long term committments

Services Provided Across All Tiers

Based on your selected tiers, we prioritize the highest-impact work from our comprehensive service portfolio.

Quality Assurance Core Services

  • Technical design quality review on deliverables
  • Design review facilitation and documentation
  • Design History File (DHF)/Medical Device File creation & maintenance
  • Supplier evaluation and management
  • Root cause investigations
  • Risk management plan and risk assessments
  • Incremental risk assessments for design changes
  • Internal training on medical device development
  • Assesses change impact to product & compliance
  • SOP, work instruction, and template updates

Strategic Advisory Services

  • Risk management strategy and risk assessments
  • QMS scaling strategy as company grows
  • Regulatory requirement interpretation
  • Corrective action strategies for major issues
  • Program schedule review and risk management
  • Supplier selection and qualification strategy
  • Design change trade-off guidance
  • Organizational structure recommendations
  • Clinical and pre-clinical study planning
  • Pre-submission meeting preparation
  • FDA question and audit observation responses
  • Complex regulatory issue troubleshooting

Included For All Tiers at No Additional Cost

Complete QMS Implementation

Startup-ready Quality Management System with SOPs and templates for design controls, document control, risk management, supplier evaluation, and more.

✓ Configured to your team’s roles and responsibilities

✓ Document and Record Control procedures

✓ Risk Management templates

✓ Supplier Evaluation and Quality Agreements

✓ Quality Manual

✓ Guide to medtech termibilities.

Compliant Document Control

Full document control repository with 21 CFR Part 11-compliant electronic approvals, version control, unlimited storage, and support for up to 10 users.

✓ Document routing and approval workflow management

✓ Electronic storage with no limits

✓ 21 CFR Part 11 electronic approvals

✓ Complete version control and audit trails

✓ HIPAA and SOC 1/2/3 ready

✓ User access (up to 10 users)

Partner Network Access

Connect with vetted biocompatibility consultants, sourcing specialists, and other specialists for occasional projects and meetings.

Coordination and small projects/meetings are included within your monthly fee.

WHY FRACTIONAL LEADERSHIP
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