Guides/Design and development

Product1:12

Design and development

Design controls from user needs to validation, with configuration items, baselines, releases and label masters.

Watch on YouTube

Design controls from user needs to validation, with configuration items, baselines, releases and label masters. Design projects, design controls, configuration items and labels.

What you'll see

1
Design and development: from the first idea to a released product.
2
Design Projects give an overview of each development project and its phase.
3
Design Development holds the design controls for each product.
4
Inputs, outputs, reviews, verification and validation are kept in one record.
5
Configuration Items list the parts and software that make up the product.
6
Baselines freeze an approved set of items.
7
Releases record what was shipped, and when.
8
Label Masters control the approved text and artwork of each label.

The screens show sample data for a fictional company, Nordic MedTech Oy. Captions are on screen and available as a CC track.

See all modules See pricing & plans Book a demo

See how MoniDoseQMS handles this

Book a 30-minute demo, or request a 14-day trial. Trial accounts are activated after a short review.

Book a 30-min demo Request a 14-day trial

Back to all guides

More guides

MoniDoseQMS in two minutes

A two-minute tour of the whole system: what is in it, how it is organised, and how the parts connect.

Build your own QMS

Register an account and assemble your quality system from only the modules you need. Set up in minutes, with no implementation fee.

Getting started

How to sign up: create a company, join an existing one with a code, or register as an expert firm or notified body.

Your everyday tools

Where your work starts each day: the dashboard, your tasks, notifications, module search and the user guide.

Document control and quality events

Controlled documents with approvals, plus the quality events that keep a QMS alive: changes, deviations, non-conformances and CAPA.

Audits and QMS governance

Plan and run audits, record findings, hold management reviews, and keep regulatory deadlines on one calendar.

Risk and vigilance

From the risk register to complaints and vigilance: how MoniDoseQMS follows a product after it reaches the market.

People and competence

Who needs which training, who has completed it, and where the skills gaps are.

Suppliers and purchasing

Approve and monitor suppliers, score their performance, manage contracts and raise purchase orders.

Device verification tests

Test records for the device itself: dosing accuracy, alarms, battery safety, interoperability, EMC and biocompatibility.

Process and operational validations

Validation projects with protocols and results: process, software, test method, shipping and cleaning validation.

Software and cybersecurity

For devices with software: lifecycle records, anomaly tracking and cybersecurity assessments.

Production and operations

The shop floor in the QMS: work orders, batch records, product release, equipment qualification, calibration and maintenance.

Products and materials

The master data everything else refers to: products, materials, bills of materials, inventory, assets and safety data sheets.

Regulatory affairs

What you need for market access: technical documentation, GSPR checklists, declarations of conformity, UDI, EUDAMED and submissions.

Clinical and post-market

Clinical evidence and post-market follow-up: literature reviews, clinical evaluation, PMS, PMCF and PSUR.

EU AI Act compliance

Twelve modules for the EU AI Act: inventory and classification, risk, data governance, transparency, human oversight, conformity and registration.

Work with regulatory experts

Find a vetted regulatory expert, ask for a review of a module, and handle quotes and invoices in the same place.

Work with a regulatory expert

How a manufacturer finds a regulatory expert, accepts a quote, gives the expert time-limited access to chosen areas, and sees every step they take.

The expert workspace

How an expert firm works in MoniDoseQMS: take on requests, send quotes, work inside a client's system with the access they grant, and invoice the hours.

Work with a notified body

How a manufacturer finds a notified body, follows its engagement and audits, answers findings, controls access to its records and receives its certificate.

The notified body workspace

How a notified body runs its certification work in MoniDoseQMS: engagements and quotes, audits and findings, certificates and EUDAMED, and the competence of its team.