Know-How Set · Medical Devices QMS
A complete QMS for medical devices, ready to use today
Ready-to-use Quality Management System documentation baseline for medical device and IVD manufacturers. Delivered to your ins2outs account in 1 hour.
Who is it for
Designed for organizations at any stage of medical device product development and QMS maturity
Medical device startup
You are building your first product and need a QMS in place before your first regulatory submission or notified body audit. The know-how set gives you a complete, audit-ready documentation structure from day one — without hiring a full-time quality team upfront.
Established manufacturer entering new markets
You have an existing QMS but are expanding to the EU (MDR/IVDR), US (21 CFR 820), or Canada. The know-how set provides documentation pre-mapped to all three markets, so you can extend your current system rather than rebuild it.
The transition from the former IVDD to EU 2017/746 (IVDR) requires significant documentation updates. This set provides all templates and procedures aligned with IVDR requirements out of the box.
If your product includes software components subject to IEC 62304, the know-how set references the relevant software lifecycle requirements and can be extended with the IEC 62304 know-how set for a fully integrated system.
Why use the Medical device QMS?
Start with expert knowledge, validated by the market
Every document, process, and role reflects how compliant medical device organisations actually operate, structured against the standards, shaped by what our customers build and ship.
Accelerate your path to market
Regulatory approval timelines are one of the biggest barriers to revenue for medical device companies. The know-how set compresses your QMS setup from months to weeks, so you can focus on what matters: getting your device certified and on the market sooner.
Cut setup time by up to 75%
The know-how set provides 170+ pre-written, structured documents: policies, processes, procedures, templates, and roles, that your team configures to your context. Combined with ins2outs and our consultants, most organizations complete their QMS definition in weeks.
Reduce project risk to near zero
QMS implementations fail when documentation gaps are discovered during an audit. With the know-how set, ins2outs platform, and our consultants, the project execution risk is reduced to near zero. Every document is traceable back to the normative source it satisfies.
Build for global markets
This know-how set targets the EU, US, and Canadian regulatory regimes simultaneously. Rather than building separate documentation sets for each market, your organization maintains one integrated QMS that satisfies global regulatory requirements.
Launch in one hour
Complete know-how set is copied directly to your ins2outs account. Your team gains immediate access to all processes, procedures, templates, and role-based training content without waiting for consulting engagements or internal drafting cycles to complete.
Standards in Medical Device QMS
Coverage across every major domain and market
Each normative source is linked within ins2outs, so you can trace every document in the set back to the specific clause it satisfies. Additional standards or market-specific regulations can be added by your organization at any time.
The documentation in this set was derived from and mapped to the following regulatory standards and frameworks.
standards
The structure that takes most teams at least 2 years to figure out and setup
This know-how set contains over 170 individual elements spanning every layer of a compliant QMS, from top-level policies and operational processes down to record templates and role definitions.
Complete QMS documentation
This know-how set contains everything required to define and operate an ISO 13485 / 21 CFR 820-compliant Quality Management System.
It includes policies, processes, procedures, document templates, normative sources, and roles — forming a systematic, audit-ready structure for any organization engaged in medical device or IVD product activities. All documents are pre-written and internally consistent, so you are not stitching together content from separate sources.
Full normative traceability
Every document in the know-how set is linked to the specific clauses of the standards it satisfies.
Normative sources include ISO 13485:2016, 21 CFR 820, 21 CFR 830, ISO 14971:2019, IEC 62304:2006, IEC 62366-1:2015, EU 2017/745 (MDR), and EU 2017/746 (IVDR). From any normative source page in ins2outs, you can see exactly which documents in your system provide evidence of compliance — and identify gaps if you add new requirements.
Role-based training built in
The know-how set defines 16 QMS roles covering both quality management and product lifecycle levels.
When a person is assigned to a role in ins2outs, they see only the content relevant to their responsibilities — reducing information overload and making onboarding faster. Training and awareness records are maintained automatically through ins2outs acceptance tasks, giving you auditable evidence of competency management without manual tracking.
Ready to use, designed to be tailored
Elements that require organization-specific input are clearly marked with TODO: strings, so your team knows exactly what to configure and what is already complete. The set also establishes a default documentation structure for both QMS and product lifecycle levels — giving your system a clear, consistent architecture from the start.
How to purchase Medical device QMS know-how set
Place your order
To purchase the know-how set, submit a request using the contact form below. ins2outs will issue an invoice covering the one-time net fee. Once payment is confirmed, the know-how set is copied directly to your organization’s ins2outs account, typically within one hour.
Requirement: your ins2outs account must be active and have at least one paying user assigned at the time of delivery.
5 hours of free consulting included
Every know-how set purchase includes five hours of consulting at no additional cost. Use this time for ins2outs onboarding, QMS setup guidance, tailoring the know-how set to your organization, or exploring how Quality Manager as a Service could support your longer-term compliance needs. You set the schedule and agenda.
To continue beyond the five hours, see our Quality Manager as a Service (QMaaS) offering.
Your ins2outs license
Once purchased, ins2outs grants your organization a non-exclusive, indefinite license to use the know-how set content within your ins2outs account. The license is issued in exchange for a one-time fee and covers the know-how set at its current version. The content may not be resold or made available outside the purchasing organization.
Full license terms are documented in the Terms and Conditions, Chapter VI: Know-how set license.
ISO 13485 / 21 CFR 820 Know-How Set
- Defines an ISO 13485 / 21 CFR 820-compliant QMS
- 170+ ready-to-use policies, processes, procedures, templates, and roles
- Normative traceability to ISO 13485, 21 CFR 820, MDR, IVDR, ISO 14971, and more
- Includes 5 hours of free consulting
- Delivered to your ins2outs account in one hour
- Requires an active ins2outs account
- For organizations of any size
Quality Manager as a Service
- Experienced Quality Manager delivered via ins2outs
- Defines, supervises, and operates your ISO 13485-compliant QMS
- Leads certification and supports product go-to-market strategy
- For organizations with up to 50 users
ins2outs standard plan
- Cloud-hosted, secure environment
- Up to 1,000 users
- Standard features package
- Full view and edit rights
Ready to get started?
Contact us to learn how the Medical Device QMS Know-How Set can support your organization’s quality compliance and product roadmap goals.