ISO 13485 Cost and Timeline for US Medtech Start-ups

• Done for you, end to end

  We write the policies, set up the controls and evidence, run the internal audit and coordinate the independent audit. You deal with one team from first call to final report.

• Simple and quick

  A free gap assessment, then one plan with dates from day one. Effivity, our GRC automation platform, is included to keep the evidence moving.

• 8,100+ client engagements

  In 60+ countries over 20+ years, with experts who bring 30+ years of experience.

• A fixed quote

  A fixed quote follows a free gap assessment, so you know the full cost before you commit.

Every Sterling consulting engagement comes with the following, so you are not buying extras to get to the finish line:

• Effivity, Sterling's GRC automation platform, with a full-year subscription, to run your controls, evidence, tasks and audits in one place.
• Sterling Academy: preferential course access, with complimentary awareness training for your people.
• Internal auditor training for your audit team, as applicable to your standard.
• For information-security engagements, a vulnerability assessment.

These are part of the engagement, not a separate purchase. The details depend on the standard you are working toward, which we confirm during the free gap assessment.

Consulting and auditing are always separated: the people who consult never audit you. That keeps your internal audit objective and protects the independence of the CPA firm, Qualified Security Assessor or certification body that performs the final step.

Behind this are 8,100+ client engagements in 60+ countries over 20+ years, led by experts with 30+ years of experience.

The outcome. A certified ISO 13485 quality management system on a dated plan, with one fixed, all-inclusive quote and no surprise invoices from the certification body. Sterling's record is 100% success and on-time completion across 8,100+ client engagements in 60+ countries over 20+ years, with experts bringing 30+ years of experience.

For a US start-up, the timing question usually comes from one of three places: an OEM customer wants you on its approved supplier list, a distributor or regulator outside the US needs a certificate, or investors want to see a quality system that will stand up to FDA. FDA itself does not require a certificate; it states it will not require or issue certificates of conformance to ISO 13485^[2]. Its rule, though, requires covered manufacturers to document a quality system that complies with the applicable requirements of the standard^[1], so the work is needed either way.

The outcome. You know which levers move the quote before you request it. A fixed quote follows a free gap assessment, and these are the factors it weighs.

The outcome. A sequenced plan you can share with your board, customers and investors. Sterling sets the dates for your plan after the free gap assessment, once scope, sites, design controls and supplier-run processes are clear.

1. Free gap assessment. Sets scope and the work list. 2. Build the system. Procedures, the risk management framework and supplier controls. 3. Run it and create records. The system must operate long enough for the auditors to sample real design reviews, supplier evaluations, training, complaints handling and CAPA. 4. Internal audit and management review. Including closing findings. 5. Stage 1 audit. The certification body reviews your documentation and readiness, usually remotely or in a short visit. 6. Stage 2 audit. The body audits the system in operation; any nonconformities must be corrected before the decision. 7. Certificate decision. Made by the accredited certification body.

How long the whole route takes depends mostly on whether design controls are in scope and how mature your records already are; without design controls, or with records already in place, it is shorter.

Certification is not the finish line. FDA describes third-party audits as occurring annually based on a three-year plan^[2], so budget time each year for a surveillance audit and keep your internal audits, management reviews and CAPA records running between them.

The outcome. We remove these delays before the certification body sees them.

• Design history built after the fact. Reconstructing design inputs, reviews and verification takes longer than recording them as you go.
• Suppliers without agreements. A contract manufacturer or sterilizer with no quality agreement holds up the supplier controls auditors look for.
• No market feedback yet. Pre-revenue firms still need working complaint and feedback procedures, even with few records to show.
• A moving design. Major changes mid-project mean rework of risk files and verification.
• Software without lifecycle records. Device software built in fast sprints still needs requirements, verification and release records that an auditor can trace; we fit these into the tools your engineers already use.
• Undefined scope. Leaving it vague until Stage 1 invites findings; we fix sites, products and activities at the gap assessment.
• Certification body calendars. Audit dates book up; we reserve them early.

This is Sterling's recommendation, not an FDA requirement.

1. Build design controls from the first prototype. FDA notes that devices made under an investigational device exemption are not exempt from design and development requirements^[3]. Records created now save a rebuild later. 2. Start the gap assessment when a customer, distributor or investor names a date. Work back from it using the phases above. 3. Scope one site first. Add sites once the system runs smoothly. 4. Put quality agreements in place early with every supplier that makes, sterilizes or tests for you. 5. Plan certification and FDA readiness together. One system serves the certification body and an FDA inspection; see our ISO 13485 and FDA QMSR guide.

Want a dated plan and a fixed number? Get started with a free gap assessment request.

ISO management system standards such as ISO/IEC 27001, ISO/IEC 42001 and ISO 9001 are certified by an accredited certification body, not by a consultant^[1]. Sterling never certifies. The certificate carries the name of the body that issued it, and that independence is what makes it credible to your buyers.

What Sterling does is prepare your company so that the certification body's audit goes smoothly. We coordinate:

• a gap assessment against the standard;
• the management system itself: scope, risk assessment, policies, procedures and records, sized for your company;
• training for your people and an internal audit before the certification audit;
• management review and corrective actions;
• the certification audit process, from choosing an accredited body to closing any findings.

Consulting and auditing are always separated. The people who consult never audit you, so the internal audit is a genuine test and the certification body's audit is independent.

Sterling has completed 8,100+ client engagements in 60+ countries over 20+ years, and our experts bring 30+ years of experience.

^[1] About the IAF MLA (multilateral recognition arrangement). International Accreditation Forum (functions transferred to Global Accreditation Cooperation Inc., 1 Jan 2026). accessed October 23, 2026.

• ISO 13485: standard overviewStandard overview
• Meet US Contract, MSA and RFP Compliance Clauses FastUnited States
• Win Buyers Abroad: Compliance for US Companies ExpandingUnited States
• ISO 13485 and FDA's QMSR: What US Device Makers Need to KnowUnited States
• ISO 13485 for US Medtech Companies: What FDA and Device Buyers ExpectUnited States
• Sterling in the United StatesUnited States

1. 21 CFR Part 820, Quality Management System Regulation (sections 820.1, 820.3, 820.7, 820.10, 820.35, 820.45). eCFR (Office of the Federal Register). accessed October 26, 2026.

2. Quality Management System Regulation: Frequently Asked Questions. U.S. Food and Drug Administration. accessed October 26, 2026.

3. Quality Management System Regulation (QMSR). U.S. Food and Drug Administration. accessed October 26, 2026.

4. Medical Device Single Audit Program (MDSAP). U.S. Food and Drug Administration. accessed October 26, 2026.

The information on this page is provided for general informational purposes only. It is not legal advice, and it is not a substitute for advice from a qualified attorney about your own situation.

Requirements depend on your scope, your customers' contracts, your industry and the regulations that apply to you. Two companies asking for the same standard can have very different obligations. We confirm yours during a gap assessment, and we update our content as standards change, but you should check the current text of any standard or rule that matters to you.

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