Med Device
MedDeviceCorp is a global leader in regulatory affairs consulting, specializing in medical device, drug, food, nutraceuticals, and cosmetics compliance. They provide comprehensive services including certification, clinical evaluation, registration support, biocompatibility testing, MDR and FDA submissions, and ISO 13485 certification. Their mission is to help manufacturers navigate complex regulatory landscapes efficiently, ensuring safety, compliance, and faster market access with a focus on excellence and innovation.
Industries
Nr. of Employees
small (1-50)
Med Device
Services
MDR/IVDR conformity and CE/UKCA consulting
Support for preparation of MDR/IVDR technical documentation, clinical evidence organization (CER), risk management files, selection of conformity assessment route and coordination with Notified Bodies until certificate issuance.
US FDA 510(k) preparation and submission services
Comprehensive 510(k) services including gap assessment, predicate identification, test requirement definition, dossier compilation, pre-submission support, submission and FDA follow-up, plus timeline and fee guidance.
Clinical evaluation and CER writing
End-to-end clinical evaluation services including protocol development for systematic literature searches, evidence appraisal, equivalence assessment and CER drafting aligned with regulatory guidance.
QMS implementation, gap analysis and internal audits (ISO 13485 / 21 CFR 820 / MDSAP)
Gap assessments, SOP development, employee training, internal auditing and implementation support to align organizational processes with ISO 13485, FDA QSR and MDSAP expectations.
Biocompatibility testing and materials characterization management
Design and coordination of biocompatibility testing programs (sterilization/extraction protocols, in vitro/in vivo assay selection, replicates, physiological conditions), analytical characterization (E&L) and preparation of regulatory-grade test reports.
MDSAP audit preparedness and internal audit services
Gap assessment, remediation planning, internal audit execution and documentation support to prepare for MDSAP certification and surveillance audits.
MDR/IVDR conformity and CE/UKCA consulting
Support for preparation of MDR/IVDR technical documentation, clinical evidence organization (CER), risk management files, selection of conformity assessment route and coordination with Notified Bodies until certificate issuance.
US FDA 510(k) preparation and submission services
Comprehensive 510(k) services including gap assessment, predicate identification, test requirement definition, dossier compilation, pre-submission support, submission and FDA follow-up, plus timeline and fee guidance.
Clinical evaluation and CER writing
End-to-end clinical evaluation services including protocol development for systematic literature searches, evidence appraisal, equivalence assessment and CER drafting aligned with regulatory guidance.
QMS implementation, gap analysis and internal audits (ISO 13485 / 21 CFR 820 / MDSAP)
Gap assessments, SOP development, employee training, internal auditing and implementation support to align organizational processes with ISO 13485, FDA QSR and MDSAP expectations.
Biocompatibility testing and materials characterization management
Design and coordination of biocompatibility testing programs (sterilization/extraction protocols, in vitro/in vivo assay selection, replicates, physiological conditions), analytical characterization (E&L) and preparation of regulatory-grade test reports.
MDSAP audit preparedness and internal audit services
Gap assessment, remediation planning, internal audit execution and documentation support to prepare for MDSAP certification and surveillance audits.
Expertise Areas
- EU MDR and IVDR compliance and CE/UKCA conformity assessment
- US FDA regulatory pathways (510(k), establishment registration, DMF)
- Clinical evaluation and clinical evidence synthesis for devices (CER)
- Quality management systems and audit readiness (ISO 13485, 21 CFR 820, MDSAP)
Key Technologies
- ISO 10993 biological evaluation
- ISO 14971 risk management techniques (FMEA, FTA, PHA, HAZOP)
- EU MDR and IVDR regulatory frameworks
- eCTD/electronic dossier and eCopy submission workflows