Export Control & Sanctions
EU Restrictive Measures
EU sanctions and restrictive measures demand strict compliance, requiring real-time screening and supply chain visibility to mitigate risk.
Industry — Healthcare & Medical Devices
Confident CBAM and supply‑chain compliance for complex, regulated medical products
Map multi‑material device BOMs, collect verifiable supplier data, and generate audit‑ready CBAM declarations—without disrupting QMS or time‑to‑market.
From data to legal
Medical devices combine metals, polymers, electronics, sterilization, and specialized logistics across global suppliers. As CBAM and climate disclosures expand, manufacturers and distributors need product‑level, verifiable emissions data that aligns with regulated documentation and traceability requirements.
Key Regulations
Shaping the Healthcare & Medical Devices Industry
Export Control & Sanctions
Conflict Minerals
Ensuring mineral supply chains are free from conflict financing is a critical component of corporate responsibility and international security.
Circular Economy
Battery Act (EU) & Digital Passport
Regulation (EU) 2023/1542 sets new rules for industrial, EV, and LMT batteries, requiring traceability and digital reporting across the lifecycle.
Product & Food Safety
General Product Safety (GPSR)
Set to apply from December 13, 2024, the GPSR modernises the EU’s product safety framework, introducing stricter rules for online marketplaces and all economic operators.
Carbon Emissions
EU Deforestation
Navigate the EU Deforestation Regulation with Artem’s advanced traceability and due diligence platform, ensuring your products are compliant and sustainable.
Meet the Artem experts
Our team of experts is dedicated to providing tailored solutions for compliant industries.
Our team of experts is dedicated to providing tailored solutions for compliant industries.
Accelerate with Confidence
1
Remove Bottlenecks
Automate tasks that slow your teams down.
2
Avoid Penalties
Stay compliant and avoid costly fines.
3
Prove Sustainability
Meet ESG goals with verified data.
4
Scale with Certainty
Expand globally without compliance risk.
Turn Regulatory Burdens into Market Opportunities
Shipping Delays & Border Holds
Missing a CBAM report or chemical disclosure can stop shipments at customs.
Trusted Supplier Status
Position your company as a reliable, fully compliant supplier. Fast customs clearance becomes a selling point to buyers who value supply chain resilience.
Rising Costs
Tariffs, penalties, and manual compliance systems erode margins.
First-Mover Advantage
Be early in meeting emerging standards and dominate new regulatory-driven market segments.
Loss of Market Access
Regulations like the EU Battery Regulation are now entry barriers. Missing them means missing customers.
New Pricing Models
Offer sustainability-based pricing (e.g., green premiums) where customers pay more for verified low-carbon products.
Brand Risk
Consumers and OEM partners increasingly demand sustainability proof. Regulatory violations can lead to lost contracts and media exposure.
Differentiation via Transparency
Make your compliance and sustainability data public—turning compliance into brand equity.
Your Partner in Healthcare & Medical Devices Compliance
1
Supply Chain
Complexity?
We’re built for it. Thousands of components, hundreds of suppliers—our tools are made to handle it.
2
Technology-Driven
Regulation?
We specialise in AI, IoT, and edge compliance tools that meet the data-heavy demands of new EU regulations.-Driven Regulation?
3
End-to-End
Visibility?
We connect sourcing, manufacturing, and market-entry compliance in a single, integrated platform.
Your Challenges:
How We Solve Them
How to navigate CBAM for Steel & Aluminium?
CBAM Platform & Authorized Representation
Automates emissions reporting and declarations. Submits on your behalf to maintain EU access and cut carbon tariffs.
How to comply with EU Battery Regulation?
MES + Emissions IoT Hardware
Tracks carbon footprint, automates due diligence, and generates Digital Battery Passports. Compliance from mine to factory.
How to certify Robotics & Gigafactory Machinery?
Lex Machina (AI-Powered Machinery Compliance)
Speeds up CE certification with automated docs, risk analysis, and compliance reports. Cuts approval time significantly.
How to manage Chemical Compliance & ELV traceability?
MES + Supply Chain Traceability Platform
Tracks materials across your value chain. Supports SVHC verification, SCIP reports, recycled content tracking, and ELV compliance.
How to integrate export controls for dual-use components?
Integrated Export Control Module
Flags high-risk parts, screens legally before shipping, and ensures global trade is secure and audit-ready.
