CfQ VIP / MDDAP Appraisal Services
Medical Device Discovery Appraisal Program + FDA Voluntary Improvement Program
For FDA-listed medical device manufacturers. Use the official CMMI framework under the ISACA + FDA collaboration to improve capability, streamline regulatory interactions, and unlock inspection relief. Entry via 1-Day Quick Check (creditable).
Delivered globally by Demix — Strategic CMMI Institute Partner with 7 Lead Appraisers and a 10-member MDDAP appraisal team (7 ATLs).
Why a dedicated appraisal engagement?
Most organisations benefit from an expert, independent read before committing to a full benchmark or entering regulated programs. A focused consultation surfaces scope, readiness, and realistic timelines — without the commitment of a full appraisal.
Preparing for your annual reappraisal?
Download the one-page Sponsor Preparation Guide — a practical checklist covering scope strategy, evidence prep, and Checkpoint 3 readiness for MDDAP/VIP site sponsors.
What sets Demix appraisals apart
By the end of our engagement you receive:
- ✅ Deep bench: 7 CMMI Lead Appraisers (incl. High Maturity) and the largest MDDAP ATL team available from a Strategic Partner.
- ✅ Global delivery with capacity for parallel and large-scope programs.
- ✅ Domain specialists (HM, medical-device/MDDAP, information security PhD).
- ✅ Proven MDDAP/VIP delivery track record with FDA-listed manufacturers (case studies available on request).
All appraisal work is consultation-led and quote-based. No public pricing is published.
Why Demix
Founded 2007. ISACA Accredited Training Organization. One of only three Strategic CMMI Institute Partners worldwide (of 326).
- 🎓 7 MDDAP Lead Appraisers (ATLs) + 10 ATMs — deepest specialist bench for med-device and regulated work.
- 🏥 Aligned with FDA 2023 VIP guidance: risk-based inspection planning, quarterly check-ins, critical-to-quality focus.
- 🌍 On-site delivery standard (most MDDAPs); global reach with HM + security depth.
- 📋 5-year program structures typical; tailored consultation-led engagements for med-device regulatory programs.
When your requirement is tied to contracts or regulated environments, you want a partner with both the standard and the technical depth — and the team to deliver.
How it works
- Complimentary consultation — scope, target OU, Quick Check vs full MDDAP/VIP.
- Engagement — collaborative discovery appraisal with your team.
- Findings + roadmap — report + support for VIP participants (quarterly cadence).
See: What is CfQ VIP / MDDAP? (framework explained)
Consultation-led. Low friction to start.
Book a complimentary consultation with a Lead Appraiser. We will scope the right engagement (Quick Check, Evaluation, Benchmark, or MDDAP/VIP) and provide a clear proposal tailored to your timeline and target outcome.
Frequently asked
Is MDDAP a standard Evaluation appraisal?
No — it is a tailored, collaborative discovery model developed under the FDA Voluntary Improvement Program. Very few standard Evaluations are performed.
What is the 1-Day Quick Check?
A low-risk, fully creditable entry diagnostic that produces a readiness snapshot and recommended path into full MDDAP/VIP.
Do you publish pricing?
No. Appraisals are consultation- and quote-led services. We provide tailored proposals after a complimentary consultation.
Can you support global on-site work?
Yes — Demix has delivered MDDAP engagements internationally with a large on-site-capable bench.