CE Marking
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Getting a product to market is not just about building it well. It is about ensuring the product meets every regulatory, safety, and market-entry requirement in every market you want to sell it in and that your innovation is legally protected before someone else claims it.
At iMAC Design and Engineering, compliance and IP strategy are not services we offer after your product is designed. They are disciplines we integrate from the first engineering decision.
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Compliance and IP strategy is the practice of ensuring your product meets all applicable regulatory and market-entry standards — while protecting the innovation inside it — before anyone else can copy it or block it.
A design decision made without IP awareness can destroy patentability. A material selection made without compliance awareness can fail RoHS at the BOM stage. These are not separate workstreams.
iMAC is ISO 13485:2016, ISO 9001:2015, and ISO 27001:2013 certified. We do not advise on standards we have read about. We operate under them every day.
Of All Patent Applications Filed in India, Are by Foreign Companies
Median Time From Product Idea to First Competitor Copy in Hardware
Engineering Design Decisions With IP Implications Go Unidentified Without a Strategy
Products That Fail First Certification Test Due to Issues Detectable at Design Stage
A compliance failure at formal certification testing means:
iMAC integrates compliance requirements into every engineering decision — material selection, PCB layout, enclosure design, shielding — before prototyping. By the time your product enters formal testing, the failure points have already been addressed.
That means shorter approval cycles, lower redesign costs, and faster entry into the markets that matter.
Every market. Every standard
Built as a launch-readiness checklist so your team can see every compliance stream in one place.
CE Marking
BIS Certification India
RoHS & REACH
EMC / EMI Compliance
IEC Standards Mapping
UL / North American Standards
CDSCO - Medical Devices India
An internal design review before formal certification begins. The goal: find what would fail - and fix it during engineering.
We cover:
Standards applicability assessment for your product and target markets.
Gap analysis against applicable regulatory requirements.
EMC-conscious PCB layout and shielding review.
Safety and risk assessment alignment.
Documentation readiness check before lab submission.
Products that skip this step and go directly to formal testing face a significantly higher probability of failure - with all associated redesign and retest costs.
BIS CRS, ISI mark, FMCS for foreign manufacturers, CDSCO for medical devices.
iMAC holds ISO 9001:2015, ISO 13485:2016, and ISO 27001:2013. We support clients implementing the same systems.
Quality management documentation, process alignment, audit readiness.
Medical device QMS, DHF structure, risk management framework, CAPA processes.
Information security policies, access controls, incident response, supplier security requirements.
ISO 13485 aligned development. IP strategy from Week 1. Regulatory pre-compliance is built into engineering. Now in active clinical use.
View Case StudyWhen you share an unprotected idea with anyone — including us — you are taking a risk. We understand that. Here is exactly how we make sure that risk is zero.
Binding NDA signed before any information is shared. Legal protection in place from the first conversation.
Access to your files, drawings, and specifications is granted only to team members directly working on your engagement — and revoked when the project closes. Backed by ISO 27001:2013 certification.
Each client project is maintained separately, with independent documentation, restricted access, and no shared resources between engagements.
Tell us your product, your target market, and your launch timeline. We will map the compliance pathway, identify what is worth protecting, and give you a clear picture of what needs to happen and in what order.
We respond within 24 hours. NDA signed before anything is shared.
Everything you need to know about IP protection and strategy.
Compliance ensures your product meets mandatory regulatory standards. CE in Europe, BIS in India, UL in North America — before it can be legally sold. Issues found after launch cost significantly more to fix than those caught during engineering. It is a design input, not a final checklist.
CE marking is required for the European Economic Area — self-declared by the manufacturer against EU directives. BIS is mandatory for specific product categories in India — requiring third-party lab testing and BIS registration. Different markets, different standards, different processes. A CE-marked product does not automatically meet BIS requirements.
An internal design review before formal lab testing. It identifies EMC issues, safety concerns, and documentation gaps while they are inexpensive to fix. It does not replace formal certification — it significantly increases your probability of passing it first time.
RoHS restricts ten hazardous substances — including lead, cadmium, and mercury — in electrical and electronic equipment sold in the EU. Most cost-effectively addressed at BOM stage, before PCB finalisation.
BIS CRS for electronics: 4–8 weeks. ISI mark: 3–6 months including factory inspection. CDSCO Class A medical device: 3–6 months. Documentation readiness is the biggest factor affecting the timeline.
An analysis of active patents confirming your product does not infringe existing rights in target markets. Needed before tooling investment, new market entry, or production scale-up — when redesign would be costly.
A patent search assesses whether your innovation is novel enough to patent. An FTO search assesses whether commercialising your product would infringe someone else's existing patent. Both are needed — at different stages of development.
In India — before public disclosure, or within 12 months under specific conditions. In the US — within 12 months of inventor disclosure. In Europe — no grace period; disclosure before filing destroys novelty. File before you launch. If already launched, seek advice immediately on what protection remains available.
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