A Manufacturer’s Guide to Product Compliance: Why Testing Early Saves Money and Protects Your Product Launch Webinar

Webinar chapters 

 

Total runtime is about 31 minutes. Use the timestamps to jump to a topic in the recording below. 

 

• 0:00 — Introduction and agenda 

• 2:42 — The smartwatch case study 

• 6:11 — What needs to be verified and validated 

• 9:17 — The compliance journey through product development 

• 13:08 — The tiers of approval 

• 20:36 — When a lifestyle claim becomes a medical claim 

• 22:44 — The cash flow case for spending early 

• 27:44 — Takeaway messages 

 

Why product compliance is a design input, not a final checkpoint 

 

Product development is usually drawn as a straight line: concept, design and development, pre-production, verification and validation, then manufacture and commercialization. Verification and validation sit near the right-hand end of that line, and that placement is the problem. 

 

  

Requirements do not work that way. Standards contain construction requirements as well as test methods: a fuse must be fitted, a creepage distance maintained, a safeguard present. Radio technologies have to operate on frequencies and power levels permitted in your target markets, and those allocations differ between the FCC rules and the Radio Equipment Directive. None of it can be retrofitted to a finished device. A failed EMC scan can mean a new PCB layout, different shielding, or a component change — and each change invalidates evidence already generated, so the program pays for the same testing twice. 

 

What verification and validation actually cover in product compliance 

 

Verification asks whether the product has been built to its specification. Validation asks whether it performs safely and effectively where it will really be used. Both are broader than regulatory testing. 

 

For the smartwatch: 

• Is the heart rate, blood oxygen, and step measurement accurate enough to support the claim on the box? 

• Does it work across the temperature, humidity, dust, and vibration it meets on a wrist, and survive distribution by road and air? 

• Does it interoperate with the earbuds and phones its users own, is the battery safe, and does over-the-air performance hold up when the body blocks the signal? 

 

Element’s experience across customer programs is that verification and validation absorb between 40 - 50% of the time and money spent bringing a connected product to market — too large a share to leave until the schedule is committed. 

 

Product Compliance: The four tiers of approval a connected product may need 

 

These layers are not interchangeable. A product can be fully compliant and still disappoint customers, or perform beautifully and remain illegal to sell. 

 

Fit-for-purpose testing: the right to market the device 

Functional and accuracy testing, environmental exposure, vibration and shock, battery life, reliability, packaging, and interoperability — the evidence that the product does what the datasheet claims. 

 

Regulatory compliance: the right to sell the device 

EMC and radio performance, product and battery safety, RF exposure, cybersecurity, restricted substances, and labelling. The route differs by market, so worldwide distribution needs a coordinated global market access plan rather than unconnected certification projects. 

 

Industry certification: the purchasing requirement 

Bluetooth, Wi-Fi, Matter, Zigbee, and Thread conformance programs are rarely a legal condition of sale but frequently a commercial one. Users look for the logo because it tells them the device will pair with what they own. 

 

Carrier acceptance: permission to join the network 

Cellular products may also need acceptance from a network operator, which controls what is allowed onto its spectrum. In North America, that typically means PTCRB certification plus carrier-specific requirements, and it often sits on the critical path. 

 

When a lifestyle claim becomes a medical claim and how does that impact product compliance 

 

Classification rests on the claims the manufacturer makes, not the sensors fitted. Once a device informs a health decision — flagging an irregular rhythm, predicting an ovulation window — it moves toward the medical device frameworks, clinical validation evidence, and IEC 60601-1-2 EMC requirements. Our whitepaper on wireless medical device compliance covers that boundary. 

 

When should you test and certify in your product compliance programme? 

 

Final certification testing needs a design and software build that represent what will be manufactured and sold. That does not mean waiting until then to do any compliance work. 

 

Concept and feasibility 

Define intended use and claims, the technologies involved, the target markets, and the applicable regulations and approval schemes. Conflicts surface cheaply here: a proposed radio technology or module may not be usable in every market on the forecast. 

 

Design and development 

Review schematics, layout, components, enclosure, and antenna integration against the relevant standards, then flow the same requirements to suppliers. Where a supplier offers a pre-approved radio module, check the scope of that approval closely — it supports an end-product program but does not complete it. Our whitepaper on the ETSI EN 300 220-2 V3.3.1 update shows how a standards revision can change what existing evidence covers. 

 

Pre-compliance and de-risk testing 

Some things cannot be assessed from datasheets. EMC is the standard example: individual parts may each have supporting data, but emissions and immunity behavior only becomes real once everything is assembled and running together. A prototype does not need to be certification-ready for an early scan to be useful — only representative enough to show whether the design is heading in the right direction. Our on-demand webinar on EMC pre-compliance offers practical insights for engineers.  

 

Final compliance testing and certification 

When compliance has been managed throughout, final testing becomes the last piece of the jigsaw — the step that generates the reports and certificates needed for market access. 

 

Product compliance: How testing early protects profit 

 

Steve makes the commercial argument with a cash flow curve. A program borrows money, spends it, and stays cash-negative until launch. Revenue then builds until end of life — and end of life is set by the market, not the manufacturer. However clever the product, a 3G design becomes obsolete when the network is switched off. 

 

 

A late failure moves the launch to the right, and the recovery work is expensive on its own: root cause investigation, engineering changes, new prototypes, repeat testing, rescheduled production. The larger cost is time. Because the market absorbs product at its own rate, a delayed launch does not compress into a steeper revenue ramp — it removes months from the selling window, and those months are gone. Spending earlier reverses this, moving the launch date left and a larger commercial window for manufacturers. 

 

Steve’s 4-step product compliance checklist to spend early and save money 

 

1. Plan verification and validation during design, not once the product is finished.
2. Document a compliance strategy covering markets, regulations, standards, and approval schemes. 
3. Flow that strategy to the design team and the supply chain so everyone works to the same criteria. 
4. Identify milestones for de-risk testing on what suppliers cannot answer for you, EMC above all. 
5. Keep monitoring standards after launch — cybersecurity obligations that did not exist at design time are now mandatory. 

 

Conclusion: make final certification the last step, not the first test 

 

Early planning will not remove every technical problem, but it creates room to find risks and fix them before tooling, distribution agreements, and customer commitments are in place. The final test program then confirms what the team already expects rather than exposing something fundamental. Failing to plan, as Steve puts it, is a plan to fail — not for the product, but for getting it to market on time. 

 

Element supports manufacturers with regulatory advisory work, test planning, pre-compliance evaluation, accredited wireless and EMC testing, certification and approvals, and global market access across 167 countries.  

Speak to Element’s Connected Technologies team to discuss a compliance strategy or test program for your product and target markets.