Regulatory strategy and support
Identify and implement pathways to introduce and maintain your innovation in global markets
Lucid’s integrated compliance capability can drive efficient market access in regulated markets from day one.
Accredited to ISO 13485 for design and manufacturing, with longstanding track record in fire, safety and security development, our team experiences the issues clients face daily.
We implement a proportionate approach, prioritising regulatory necessities, aligning to commercial realities.
Integrated regulatory intelligence delivers;
Informed
project planning
Budget and schedule
compliance implications
accurately.
Gap analysis for regulation, guidance and standards in highly-regulated markets
Comprehensive
compliance
management
Expertise in certification to standards including:
Biological, electrical and
electromagnetic safety,
digital communications, fire, security explosive
environments.
Market access and ISO 13485 manufacturing
Product audit planning and implementation:
​
Seamless transfer to
production at Lucid, your
facilities, or our trusted
network.
Accelerating and de-risking your product development with:
Regulatory and standards gap
analysis
Compliance budgeting and
scheduling
Design requirements and specification
management
ISO 14971
compliant risk management
ISO 10993-1 biological safety
IEC 62366-1
human factors
IEC 62366-1
human factors
IEC 62304software life-cycle
EN54/50131
fire and security
compliances
ATEX/IECEx
explosive
environments
DTAC, health information and security standards
Regulatory
and certification body liaison
Mitigating risk through design