01Advise
Executive QA/RA advisory
Independent senior judgement on quality and regulatory strategy, material risk, priorities and the decisions leadership needs to make.
Executive QA & RA consultancy
Senior judgement.
Practical leadership.
Work delivered.
When critical quality and regulatory work needs to succeed, I make sure the right work gets done.
How I work
Advice is only valuable when it changes what happens next.
I turn complex quality and regulatory requirements into clear decisions, accountable actions and completed work. Clear on risk, pragmatic in execution and accountable for outcomes—from executive strategy through implementation and closure.
How I can help
Advise. Lead.
Deliver.
Senior support for organisations that need more than recommendations: the right direction, experienced ownership and work brought to completion.
02Lead
Fractional & interim QA/RA leadership
Senior ownership of the function or programme—building, coaching and mentoring capable QA/RA teams, strengthening governance and keeping critical work moving through change.
03Deliver
Defined QA/RA programmes
Hands-on delivery of QMS and ISMS implementation, audit and certification readiness, remediation and critical regulatory documentation.
Selected outcomes
Proof in the work.
Clients engage Bright Future PharMD not only to understand what is required, but to achieve the required outcome.
01Medical devices & pharma quality
From scratchISO 13485 QMS established
Established quality management systems from the ground up and led successful ISO 13485 certification, with broader experience developing and strengthening quality systems aligned with FDA QMSR and pharmaceutical cGMP requirements.
02Medical devices & IVDs
Findings reducedMDR & IVDR remediation
Led gap remediation and hands-on development of CER, PER, SOTA, PMS, PSUR and risk-management documentation, strengthening technical files and reducing findings.
03Diagnostic laboratories
Audit leadershipISO 15189 laboratory quality
Performed the lead-auditor role for ISO 15189 assessments, translating identified gaps into implemented improvements across laboratory quality processes and diagnostic operations.
04AI & information security
3 monthsISO 27001 certification
Led the design and implementation of an information security management system for an AI company, achieving successful ISO 27001 certification within three months.
About the founder
Science understood.
Business considered.
People aligned.
Work delivered.
Dr Yuedan Li is a senior quality and regulatory leader with more than 20 years across healthcare and medical technology, spanning R&D, product development and senior QA/RA leadership in biotechnology, pharmaceuticals, medical devices and molecular diagnostics.
Combining a PhD in cell physiology with an Executive MBA, Yuedan brings scientific depth, independent judgement and a practical business perspective. She advises senior management, leads teams and complex programmes, and remains engaged until the work is successfully completed.
20+ yearsHealthcare & life sciences
PhD · MBAScience & business leadership
EU · US · ROWGlobal QA/RA experience
QualifiedISO 13485 Lead Auditor · PRRC
Applied expertise
ISO 13485 QMS & GMP systems MDR & IVDR ISO 15189 audit leadership ISO 27001 ISMS implementation FDA QSR & MDSAP GMP · GDP · GCP ISO 14971 · IEC 62304 · CSV R&D · product development · project & programme leadership
Start a confidential conversation
Let’s discuss what
needs to be
delivered.
If you need independent senior advice, fractional or interim leadership, or experienced delivery of a critical QA/RA programme, get in touch.
yuedan@brightfuturepharmd.comLeiden, the Netherlands · Available internationally