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What goes into an ideal design services RFQ for a safety-critical device concept

Project timeline:
months
Service areas:
Product development
Written by
Teija Tulinen
Innokas content writer
Innokas employee on a laptop with accompanied by "Innokas sustainability report 2024" title

Published on 5.8.2026

You have a mature concept for a device and it’s time to think about further design aspects. You might have entertained outsourcing as a possibility, and a few potential partners may even have contacted you already. What does an ideal request for tender look like, one that will result in easily comprehensive and comparable offer? When is the right time to make one? And what about the format?  

Use this checklist to ensure you know everything that should go into a high-quality tender request for a design services provider and look forward to clear and comparable proposals for your project.

When is the right time to bring a partner into the project?  

The ideal phase to bring in a suitable partner is when the concept is defined enough to accurately describe user needs, constraints, and intended use, but early enough for your partner to influence architecture, risk mitigations, and feasibility decisions. This is important because safety-critical technology, like medical technology, must be developed under structured design‑control frameworks that cover foundational aspects of your device, like design inputs, outputs, verification, validation, and design changes. Starting the work without considering these will turn into costs.  

Furthermore, partners can only provide accurate costs and schedule forecasts once core design inputs like essential requirements, environmental conditions, and safety constraints are available. Early partner involvement also helps you refine requirements and traceability systems that support compliance with frameworks like ISO 13485 and FDA design regulations.  

Practical rule of thumb:

Send the RFQ once you can articulate what the device must achieve (functional requirements, performance targets, critical risks) but before locking major engineering decisions. This balances clarity with flexibility.

Don’t forget: Treat the RFQ as an iterative, collaborative stage

Many innovators assume they must produce a perfect tender before engaging partners, but that’s actually only the beginning. High‑quality RFQs are always refined in collaboration with respondents. Clear instructions and iterative clarification channels are essential for an effective tender process. Allowing suppliers to ask questions and request additional detail significantly improves the accuracy and comparability of proposals. Structured feedback loops (pre‑submission Q&A, clarification calls, updated annexes) lead to tenders that more precisely reflect the actual project scope.

For safety‑critical design, iteration is particularly valuable because respondents may highlight risks, regulatory considerations, or design‑control activities you haven’t accounted for. Your assumptions about verification/validation planning, materials, or risk‑management burden are likely to change after a technical conversation.

State in your RFQ that you encourage technical discussion before final tender submission and welcome feedback on requirements, constraints, and assumptions. Reviewing and commenting on the RFQ in turn helps ensure that the final version accurately reflects what you need.

1. Project definition

Clearly describe the project context and goals.

  • Which problem are you eventually solving with your innovation? What, by your understanding, are the steps that take you there?
  • What outcome defines success?

Try to provide a clear overall picture. As it stands, the supplier does not know anything about your device. Think about what do you need to tell them to have them understand everything there is to know about your device. Add the necessary details, schema, architecture, etc.

Provide a high-level project scope
  • Who is responsible for development, manufacturing, testing, documentation, validation, etc.
  • Identify what is in and out of scope.
State project maturity level

Are requirements fixed, evolving, or still conceptual?

Include any TRL (Technology Readiness Level) knowledge if available.

2. Technical inputs

Provide all available technical documents. This is not necessary if there are none at the time of RFQ.

  • CAD files, schematics, BOMs, prototypes, risk documentation.

What steps do you plan to do in-house and what will you outsource? Provide a clear distinction.

  • Requirements: functional, performance, regulatory.

Make sure your potential partner knows if any of your finances are tied to an existing investment.

Specify missing items.

  • What is not known yet?
  • What are you expecting to evolve during development?

Share constraints.

  • These could be technical, regulatory, material, supply chain, or interface constraints.

Give a clear picture of your sourcing expertise. For the design project to advance smoothly, it’s necessary to understand what you buy.

3. Timeline & milestones

Indicate preferred start date and expected timeline.

  • Timelines are always highly up to change, especially in the beginning, so giving out fixed timeline is not necessary, or even possible. Your goal is to find a partner who can follow your plan to best of their ability, not perfectly. Stay flexible.

List key milestones and gates.

  • Prototype, DVT, validation, compliance, production ramp-up.

Inform about external dependencies.

  • Approvals, third-party suppliers, customer-side resources.

Tip: Coordination will take up more resources the more partners you have. Having as many things sourced from one partner will streamline development.

4. Deliverables & expectations

Define expected outputs.

  • Prototype units, test reports, design packages, documentation, certifications.

Specify required quality and regulatory standards if you are aware of them.

  • ISO, FDA, MDR, aerospace/defence specs, etc.

Clarify format expectations ISO, FDA, MDR, aerospace/defence specs, etc.

  • Document formats, reporting cadence, communication channels.

Make sure you know how well certain things need to be documented. Ask yourself, what do you need in order to confidently state that you are ready?

5. Risk, change & assumptions

Invite suppliers to state assumptions explicitly.

  • Unknowns, dependencies, expected iterations.

Ask for identification of key risks.

  • Technical, timeline, regulatory, supply chain.

Request a view on expected changes.

  • Ask your potential partner what factors are likely to evolve and drive additional cost and what is needed to minimize that additional cost.

6. Commercial information

Clarify how the tender will be evaluated.

  • Price vs. risk handling vs. technical robustness.

Specify costing format.

  • Hourly rates, fixed-price elements, NRE (non-recurring engineering), materials, prototypes.

Include any budget constraints or ranges (Optional but helpful for scope alignment).

7. Submission requirements

Provide a clear structure for responses.

  • So proposals you receive are comparable.

Indicate deadlines and Q&A windows.

  • Encourage questions early.

Define who to contact for clarifications.

  • Technical and commercial points of contact.

By following these tips, you should get comparable and clear tenders that streamline your partner selection and project ramp-up significantly. Don't worry about making mistakes or not having some of the information that was listed on our checklist. It's enough to acknowledge the gaps in your knowledge and be open to feedback from your potential partner. This is how your shared synergy gets tested from the very first points of contact long before you decide who to trust with your success.

Let us know if you have any further questions. If you are currently evaluation potential partners for product development, take a look at our product development page and fill out our contact form through the link below to get in touch with our experts.

CONTACT US

Based on an interview with

Antti Virtanen

Solution Architect, Innokas

+358 50 321 0874

antti.virtanen@innokas.eu

Antti Virtanen is Innokas expert and solution architect with over 20 years of experience in formulating solutions for product development challenges in demanding and safety-critical industries such as Medtech, from start-up level to global companies.

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