Medical device QMS consultants (ISO 13485 / QMSR)

Consultants whose sites describe medical-device quality systems: ISO 13485, FDA QMSR / 21 CFR 820, MDSAP, or EU MDR/IVDR quality requirements.

54 profiles. Looking for a iso 13485 qmsr consultant? Read our neutral hire guide before you engage anyone.

Independent directory. Listings are compiled from information firms publish on their own websites and are not endorsements, rankings or verifications of credentials. All profiles are currently unclaimed.

AaMEDI

📍 Switzerland · On-site

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Agata Porwol Compliance & Quality Consulting

📍 Germany · Remote · On-site

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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Alacrita Consulting

📍 London, UK / Cambridge, MA, USA · On-site

GMP audits & mock inspections Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Apotech Consulting

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Arslan Quality Consulting

📍 San Diego, CA, USA · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Assurea

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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BioBoston Consulting

📍 Boston, MA, USA · Remote · On-site

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Bridgepoint

📍 Eau Claire, WI, USA · Remote

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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BushmanQC

📍 Not stated on website · Remote

CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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CHRQ Consulting, LLC

📍 Seattle area, WA, USA · Delivery mode not stated

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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CIRG (Mock FDA Inspection)

📍 Not stated on website · Remote · On-site

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ClemTech Medical Solutions

📍 Not stated on website · Delivery mode not stated

CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Compliance-Science Ltd

📍 United Kingdom · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Copperhead QARA/RP Services Ltd

📍 United Kingdom · Delivery mode not stated

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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Device Quality Ltd.

📍 Ireland · Remote · On-site

QMS build-outs Sterile/aseptic & contamination control Medical device QMS (ISO 13485/QMSR)

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Double Helix Pharma UK Ltd

📍 Aylesbury, UK · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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EMMA International

📍 Miami, FL, USA · Delivery mode not stated

483 & warning-letter remediation QMS build-outs Medical device QMS (ISO 13485/QMSR)

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Entourage

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Eranova Pharma

📍 Spain · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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FDA Compliance Group

📍 Broomfield, CO, USA · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Gemica Consulting Limited

📍 Chester-le-Street, Durham, UK · Delivery mode not stated

Medical device QMS (ISO 13485/QMSR)

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GMP Auditing & Consulting LLC

📍 Malvern, PA, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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GxP Auditing and Consulting Services (GxPAuditConsult)

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Helix Life Sciences AG

📍 Switzerland · Delivery mode not stated

QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Isli Consulting

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Ken Block Consulting

📍 Richardson, TX, USA · Remote · On-site

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Limehill Quality Solutions

📍 Not stated on website · Remote

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Lucas MedTech

📍 Germany · Delivery mode not stated

Medical device QMS (ISO 13485/QMSR)

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M.P.C.A. International

📍 Belgium · Remote

GMP audits & mock inspections EU/UK Qualified Person (QP)QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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MD Compliance

📍 Glasgow, UK · Delivery mode not stated

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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MDR Consultants

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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MDRA

📍 Watford, UK · Delivery mode not stated

QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Medical Device Academy

📍 Not stated on website · Remote · On-site

483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Medizinprodukte QM

📍 Moers, Germany · Delivery mode not stated

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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Option One Consulting (OOC)

📍 Switzerland · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Panacea Clinical Research

📍 Not stated on website · On-site

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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PharmaCompliance.DK

📍 Denmark · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Pharmalane UK

📍 London, UK · Delivery mode not stated

GMP audits & mock inspections Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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PharmExpert Consultant LLP

📍 India · Remote · On-site

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PharmOut

📍 Australia · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Precision Regulatory Consulting LLC

📍 Not stated on website · Delivery mode not stated

QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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QMLogic

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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QMSAdvisor

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Qualomics

📍 Not stated on website · Remote · On-site

483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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QV-Compliance A/S

📍 Roskilde, Denmark · Delivery mode not stated

CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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R2 Pharma Solutions

📍 Australia · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Medical device QMS (ISO 13485/QMSR)

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Regulatory Leadership Partners

📍 Not stated on website · Remote

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SA Quality Solutions (SAQMS)

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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SQA Solution

📍 Daly City, CA, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity Medical device QMS (ISO 13485/QMSR)

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The Quality Consortium

📍 Ontario, Canada · Delivery mode not stated

QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Toscano Consulting Group, Inc.

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Trautmann Managementsysteme

📍 Germany · Remote · On-site

GMP audits & mock inspections QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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tri-consulting

📍 Terrassa (Barcelona), Spain · Delivery mode not stated

CSV/CSA & data integrity Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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xFDA Investigators

📍 Not stated on website · Remote · On-site

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Medical device QMS consultants (ISO 13485 / QMSR)

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