Solutions › Medical Devices
The Regulatory Burden
on Medical Devices is Relentless.
Fifteen major regulatory regimes. Continuous guidance updates. EU MDR still evolving. FDA software and cybersecurity requirements shifting. MAUDE adverse events to monitor. Predicate strategies to build. Lexim Sphere was built for exactly this complexity.
Device Lens · FDA Data Universe
The challenges your team faces every day
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14+
6
15+
Regulatory Regimes
Monitored
FDA Device Datasets
in Device Lens
AI Engines
Available
Raw PDFs
Your Team Reads
The Challenge
We know what keeps
MedTech RA teams up at night.
Medical device regulatory affairs is one of the most complex, high-stakes disciplines in industry. The volume of regulatory activity, the consequences of missing something, and the pace of change have never been greater.
The Flood of Regulatory Updates
The FDA alone publishes hundreds of guidance documents, final rules, draft guidances, notices, and enforcement actions every year. Add EU MDR, PMDA, Health Canada, TGA, and eleven other regulatory bodies — and your team is trying to drink from a fire hose, every single day.
Solved by → Synthesis · FDA Pulse · Global Pulse
Post-Market Surveillance Gaps
Your post-market surveillance obligations require you to monitor adverse events and safety signals not just for your own devices, but for equivalent products in the market. Manually searching MAUDE, tracking recalls, and benchmarking your safety profile is a full-time job that most teams don't have the bandwidth for.
Solved by → Device Lens · Periscope
SOP Compliance in a Moving Target Environment
​Your SOPs were written against a regulatory landscape that no longer exists. EU MDR brought sweeping changes. ISO 13485 requirements evolve. FDA QSR updates. Keeping your internal documentation aligned with current requirements — across all your markets — requires continuous gap analysis that manual processes simply can't sustain.
Solved by → Bridge · Vigil · Cabinet
Predicate Strategy Uncertainty
Selecting the wrong predicate for a 510(k) submission is one of the most costly mistakes in MedTech regulatory affairs — it can mean a Not Substantially Equivalent decision after months of preparation. Searching the full clearance database manually for the strongest predicate chain is time-consuming, incomplete, and often inconsistent.
Solved by → Device Lens · Predicate Finder
Competitive Intelligence Blind Spots
Your competitors are filing, clearing, and launching. Their clinical trials are progressing. Their adverse event profiles are changing. Their recall activity may signal quality system weakness — or opportunity. Most MedTech RA teams find out about competitive regulatory developments the same way everyone else does: too late.
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Solved by → Periscope · Device Lens
Global Submission Complexity
Taking a device global means navigating regulatory requirements across multiple jurisdictions simultaneously — often with documents that need translation, comparison, and alignment. The cost and time involved in technical translation alone is enormous, and cross-jurisdictional document comparison is almost always done manually.
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Solved by → Relay · Clarity · Synthesis
The Synthesis Six
Six layers of intelligence.
Every regulation. Automatically
Every document that enters Lexim Synthesis is processed through all six analyses simultaneously — so your team arrives at every regulatory update already informed, aligned, and ready to act.
Global Coverage
The regulators your
devices answer to.
Lexim Synthesis monitors all the major regulatory bodies that matter to medical device manufacturers — so your team never misses a publication anywhere in your markets.
TGA
Therapeutic Goods Administration
AUSTRALIA​
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Plain-language answers to anticipated questions — ready to share with cross-functional stakeholders who need clarity without the source document.
FDA
Food & Drug Administration
UNITED STATES​
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The world's most active medical device regulatory body — CDRH, CDER, guidance documents, final rules, 510(k), PMA, De Novo, enforcement actions.
NMPA
National Medical Products Administration
CHINA​
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Registration, clinical evaluation, and post-market surveillance requirements for one of the world's largest and fastest-growing device markets.
EU MDR
Medical Device Regulation
EUROPEAN UNION​
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EU MDR 2017/745 and IVDR 2017/746 — still evolving post-transition, with ongoing EUDAMED development and notified body updates.
ANVISA
Nat'l Health Surveillance Agency
BRAZIL​
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​Device registration and post-market surveillance in Latin America's largest and most complex regulatory market.
PMDA
Pharmaceuticals & Medical Devices Agency
JAPAN​
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Japan's comprehensive medical device regulatory framework — one of the most rigorous and detailed in the Asia-Pacific region.
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Additional Regulatory Bodies
GLOBAL​
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Lexim Synthesis monitors 15+ regulatory regimes in total — covering all major medical device markets worldwide.
HC
Health Canada
CANADA​
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Medical device licensing, mandatory problem reporting, and regulatory guidance under the Medical Devices Regulations.
By Role
Find your perspective
within the platform.
Lexim Sphere serves every member of the MedTech regulatory and quality function — from the specialist doing the daily work to the executive setting the strategy.
FOR THE LEADER
VP Regulatory Affairs
Command-center visibility across your entire regulatory landscape. Know what's changing, what it means for your pipeline, and where your team's attention needs to be — without being buried in documents yourself.
FOR THE INTELLIGENCE FUNCTION
Regulatory Intelligence Analyst
The most powerful regulatory intelligence toolkit available — Synthesis, Device Lens, Periscope, and Docket working together so you can deliver deeper analysis faster than was ever previously possible.
FOR THE SPECIALIST
Regulatory Affairs Specialist
From tracking the regulations that affect your submissions to building predicate strategies and running gap analyses — Sphere handles the time-consuming work so you can focus on the decisions that require your expertise.
FOR QUALITY
QA Manager / Director
Keep your quality system current against a regulatory landscape that never stops moving. Bridge your SOPs against evolving requirements. Monitor equivalent device safety signals. Ensure your documentation is always audit-ready.
FOR THE EXECUTIVE
C-Suite
Regulatory risk is business risk. Sphere gives executive leadership the visibility to understand the regulatory landscape affecting your pipeline, your competitive position, and your market access strategy — without relying entirely on filtered reports.
Built for MedTech
See Sphere working on
your device category.
Book a demo tailored to medical device regulatory affairs — we'll show you Synthesis processing a regulation that matters to your team, Device Lens surfacing intelligence on your competitive landscape, and Bridge analyzing one of your SOPs.