EC MedTech Consulting | Design transfer to commercial launch

Gowned technicians assembling medical devices under microscopes on a cleanroom production line — Verification · Transfer · Qualification · Launch

01 · Goals

What we're here to do

Three goals guide every engagement we take on.

Project dashboards and live schedule data on a tablet and monitors

01

Launch on schedule

Integrated plans, live dashboards and AI assisted risk forecasting, so your product reaches market when the business needs it.

An automated robotic system running tests in a modern laboratory

02

Audit ready quality

Automated testing and AI checks on documents and data, with every protocol, report and design history file built to stand up in an FDA or Notified Body review.

A team reviewing data together with an AI dashboard on a large screen

03

Build a strong team

A bench of 5 to 10 engineers who know regulated work and use modern AI tools to move faster, staying with your program from start to finish.

02 · Approach

The business idea

Most products don't stall in R&D. They stall in the handoff to manufacturing, where engineering, quality, regulatory, supply chain and outside partners all have to move together.

The problem

Transfer is where launches slip

Internal teams are stretched. Staffing firms send people who need direction. Big consultancies cost a lot and send junior staff. The program ends up with no one who can both run it and understand the engineering.

Our answer

A lead and a bench, accountable together

We pair an experienced program lead with validation, process and design engineers who already know regulated work. You get one team, one plan and one point of accountability from design freeze to launch.

A 3D printer building a device prototype — 1DesignDigital design, simulation and rapid prototypes

A collaborative robot arm on an automated production cell — 2Transfer and qualificationAutomated, validated production lines

A digital control room tracking production and supply data — 3Commercial supplyData driven supply and post market monitoring

Senior people do the workThe people who scope your program stay on it.

Engineering depthWe read the DHF, the PFMEA and the schedule with the same care.

Audit ready by defaultEvery deliverable is built to hold up in an FDA or Notified Body review.

We scale with youStart with one person and add engineers as the program grows.

03 · Lifecycle

Where we work

We focus on the back half of the product lifecycle, from verification through launch and post market.

ConceptUser needs
Inputs, early risk analysis
DesignDesign controls
DHF, DFMEA, design reviews
VerificationDV / V&V
Protocols, reports, traceability
TransferDMR · PFMEA
Process, supplier and CMO readiness
QualificationIQ · OQ · PQ · PPQ
Equipment, process and packaging qualification
LaunchPost market
Supply readiness, labeling, EU MDR updates

Gates we lead

04 · Services

Services

Six service lines, each built on programs our team has already delivered at global device and biopharma companies.

A development engineer reviewing a medical device design on a laptop with a prosthetic arm user

SVC‑01

Design and manufacturing transfer

Transfer plans, integrated timelines and readiness gates that get a product from R&D into a production line.

DMR
PFMEA
IQ/OQ/PQ
PPQ

SVC‑02

Combination product industrialization

Device assembly, fill/finish, labeling and packaging readiness across internal sites and CMOs.

21 CFR Part 4
Multi site
CMO

SVC‑03

EU MDR and post market programs

Technical File updates, IFU and label changes, UDI and remediation that keep product shipping.

EU MDR
UDI
Technical File

SVC‑04

Design controls and DHF readiness

DHF gap reviews, risk management files and V&V protocols and reports that hold up in an audit.

ISO 14971
DFMEA
V&V

SVC‑05

PMO setup and program recovery

When a program has slipped, we put in the governance that brings it back: RAID logs, RACI, dashboards and decision forums.

RAID
RACI
Dashboards

SVC‑06

Engineering bench

Validation, quality, manufacturing and design engineers placed on your program and led by our program lead.

Validation
Process
CAD / GD&T

05 · Engagement

Ways to work with us

Pick the setup that fits how your company buys outside help. Each one can grow into the next.

A consultant walking a client team through live performance charts on a large digital screen in a glass walled office

Embedded

A program lead on your team

A senior program manager joins your team, hourly, through your preferred vendor or directly.

Project

A defined scope with a deliverable

A transfer plan, a DHF gap review or an EU MDR remediation, scoped and priced under a statement of work.

Team

A lead plus engineers

A small team of 2 to 4 people with one point of accountability for the outcome.

06 · Record

Experience behind the firm

Results our team has delivered on past programs.

12+ yrsRegulated product development and manufacturing transfer

<6 moEU MDR part release, qualification and launch across 5+ international sites, ahead of schedule

$10M+Commercial combination product portfolio run under integrated timelines and governance

50+Cross functional team members led across engineering, quality, manufacturing and supply chain

07 · Careers

Grow with us

We're building a bench of engineers who want regulated product work alongside people who have done the job. New England based or remote.

An engineer in safety glasses working on production equipment

Validation / Quality Engineer

IQ/OQ/PQ, protocols and reports, CAPA, risk files

Medical device

Manufacturing / Process Engineer

Process development, PFMEA, line setup, supplier and CMO work

Device · Combo

Design Engineer

SolidWorks or Creo, GD&T, tolerance analysis, design change