# Establishment and optimization of an ISO 13485 quality management system
Do you develop or manufacture medical devices and want to implement a quality system in accordance with ISO 13485?
I support you in the design, implementation and improvement of your quality management system in order to meet regulatory requirements and prepare for your certification audits.
Services offered:

* Gap Analysis
* Preparation or update of quality documentation
* Process mapping
* Drafting of procedures and forms
* Implementation of quality indicators
* Support for ISO 13485 certification
* Preparation for internal and external audits
Deliverables:
* Analysis report
* Action Plan
* Quality documentation
* Personalized recommendations
This service is aimed at medical device manufacturers, MedTech start-ups and companies wishing to strengthen their regulatory compliance.

# Support for the risk management of medical devices according to ISO 14971

Risk management is a critical requirement for regulatory compliance of medical devices.

I support you in the implementation of a structured risk management approach in accordance with ISO 14971.
Services:

* Risk Management Plan Development
* Hazard identification
* Risk analysis
* Risk assessment
* Definition of control measures
* Verification of the effectiveness of actions
* Preparation of the risk management file

Deliverables:

* Risk Management Plan
* Risk matrix
* Risk analysis
* Risk Management Report
* Documentation that complies with regulatory requirements

# Process validation, equipment qualification and document validation

I support you in the planning and execution of validation activities in accordance with the requirements of the regulated industries.

Areas of intervention:

* IQ, OQ and PQ qualification
* Process validation
* Cleaning Validation
* Document validation
* Protocol development
* Validation reports
* Compliance reviews

Deliverables:
* Validation Master Plan
* IQ/OQ/PQ protocols
* Qualification reports
* Traceability matrices
* Action plans

# Metrology consulting and measurement equipment management

I support you in the implementation of a measurement management system in accordance with good metrology practices.

Services:
* Development of calibration plans
* Determination of periodicities
* Analysis of calibration certificates
* Evaluation of measurement uncertainty
* Verification of equipment compliance
* Management of instrument parks
* Optimization of metrology programs

Deliverables:
* Metrology plan
* Equipment tracking database
* Metrological procedures
* Evaluation reports
* Technical recommendations

# Internal Quality Audit – ISO 9001, ISO 13485 and ISO/IEC 17025

I carry out internal audits to assess the compliance of your management system and identify opportunities for improvement.

Services:
* Preparation of the audit
* Checklist development
* Conducting interviews
* Literature review
* Identification of non-conformities
* Risk assessment
* Recommendations for improvement

Deliverables:
* Audit report
* List of variances
* Action plan
* Summary of recommendations