ServicesHow I can help
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Quality systems and eQMS
Build or harmonise an ISO 13485 quality system, and select and roll out an eQMS covering CAPA, complaints, audits and change control.
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EU IVDR and MDR compliance
Practical routes through IVDR and MDR from a former Person Responsible for Regulatory Compliance: gap assessments, technical documentation and notified body readiness.
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FDA, ISO and MDSAP audits
Mock inspections, internal and supplier audits, and support for 483 and warning letter responses, from someone who has sat across the table from FDA investigators.
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Quality remediation
Structured programmes to bring CAPA, validation, design controls and complaint handling back to a state you can defend at inspection.
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Investment due diligence
Independent quality and regulatory insight for investors and acquirers: an honest view of compliance risk, inspection history, regulatory pathways and remediation cost before you commit.
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Fractional and interim VP QA/RA
Senior QA/RA leadership a few days a month. Start-ups get a quality system and regulatory plan built to scale from day one, and established teams get steady cover through a leadership change, an acquisition or a hiring gap.
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AI for quality and regulatory teams
Put the data you already hold to work. Practical AI tools for complaint trending, CAPA investigation, document review and submission drafting, introduced with the validation and controls an auditor will expect. A force multiplier for lean QA/RA teams.
StandardsISO 13485 · ISO 14971 · EU IVDR · EU MDR · FDA QMSR · MDSAP
AboutNed Merrick
Evenstar Quality is run by Ned Merrick, a quality and regulatory leader with more than 25 years in medical devices and in vitro diagnostics, including senior roles at Thermo Fisher, Siemens Healthineers and Zimmer.
Ned started on the shop floor as a process engineer making knee implants, and has since led quality engineering, design assurance, global audit programmes and QA/RA functions spanning multiple manufacturing sites worldwide. He has served as Person Responsible for Regulatory Compliance under EU IVDR, implemented eQMS platforms across global divisions, and led sites through FDA re-inspections and ISO audits with zero observations.
The name comes from the evening star, the first light to appear as the sky turns grey. That is the job: finding the clear path when the guidance is ambiguous, and explaining it plainly.