Approved Development at Highest Standards
Declaration of Compliance to ISO 13485
IPP as regulatory consultants approve that a medical device manufacture committing to the Easy13485 Quality Management Service operates an complete and effective Quality Management System according to ISO 13485. The Quality Management System is audited at installation and at a regular basis as required by the relevant standards. For details of compliance see the listing below.
Quality Management System according to ISO 13485
- Easy13485 provides a complete Quality Management framework according to ISO 13485, the standard for QMS for medical devices.
- It as assures that every relevant employee has access to his individual roles and responsibilities.
- Easy13485 supplies all necessary processes pre-audited and covers all phases of the product life cycle at a very high level.
- The manufacturers work with audit prove templates which cover all regulatory aspects.
- The quality and qualification is assured by interim PRRC and QMR or assistance as required.
Involvement of Management
It is assured that management is committed to the quality of the product in all aspects of quality management:
– Fulfillment of customer requirements
– Compliance with regulatory requirements
– Definition of quality objectives and commitment to achievement
Compliant Medical Device File according to MDR
- Easy13485 ensures all up to date requirements of the MDR to the highest standards.
- With the help of the processes and templates, the customer is guided safely and in a structured manner through the creation of the Medical Device File in accordance with the MDR.
- For each document, there are precise instructions on the standard-compliant storage location in the Medical Device File.
- The processes are individually adapted to the respective product range.
Up to date Risk Management according to ISO 14971
- Easy13485 includes the complete risk management process according to ISO 14971 covering all phases of the product life cycle.
- Documentation guides through up to date risk management templates created by IPP experts.
- IPP assist or fulfills the duties of the expert risk manager in order to fulfill risk management to professional standard.
- Risk management process is constantly triggered throughout the development process.
Regulatory Requirements Service Subscription
- All generally applicable requirements are integrated in the Easy13485 QM Service according to the highest standards.
- The experts at IPP always keep all regulatory requirement up to date.
- If there are important changes, the medical device manufacturer is immediately informed and provided with the recommended actions.
Clear Roles and Responsibilities of the Employees
- All roles are automatically aligned with qualified employees.
- It is assured, that every employee has direct access to his relevant processes and task.
- It is assured, that every employee is aware of his responsibilities, task and duties.
- The organizational chart is always up to date and shows all current roles, including the assigned employees, as well as the persons responsible for the roles and their representatives.
Up to date Software Development according to IEC 82304-1 - Health Software
- All requirements of IEC 82304-1 are integrated into the process landscape of the medical device manufacturer.
- The coverage of the standard is validated and traced into every step of product development.
- The requirements of IEC 82304-1 are integrated into general development and risk management according to ISO 14971 to align all development activities.
- Development outcome is automatically and traceable IEC 82304-1 without any additional compliance verification.
Up to date Software Development according to IEC 62304 - Medical Device Software Life Cycle
- All requirements of IEC 62304 are integrated into the Process landscape of the medical device manufacturer.
- The coverage of the Standard ist validated and traced into every step of product development.
- The requirements of IEC 62304 are integrated into general development and risk managment according to ISO 14971 to align all development activites.
- Development outcome is automatically and traceable IEC 62304 with out any additional compliance verification.
Up to date Device Development according to IEC 60601-1 - Medical Electrical Equipment
- All main tasks of IEC 61601-1 are integrated into the process landscape of the medical device manufacturer.
- The medical device manufacturer is guided through all relevant steps of development and verification.
- All relevant deliverables are covered in Stage Gate checklists to ensure complete coverage.
Compliance with Cybersecurity Standards
- All main tasks of Cybersecurity are integrated into the process landscape of the medical device manufacturer.
- The medical device manufacturer is guided through all relevant steps of development and verification.
- All relevant deliverables are covered in Stage Gate checklists to ensure complete coverage.
Up to date Device Development according to IEC 62366 - Usability of Medical Devices
- All main tasks of IEC 62366 are integrated into the process landscape of the medical device manufacturer.
- The medical device manufacturer is guided through all relevant steps of development and verification.
- All relevant deliverables are covered in Stage Gate checklists to ensure complete coverage.
- Development outcome is automatically and traceable IEC 62304 without any additional compliance verification.
Integrated Clinical Evaluation Process according to MDR 2017 / 745
- The medical device manufacturer performs the clinical evaluation of his product according to latest MDR standards and MEDDEV 2.7/1.
- All latest European guidances are considered in the evaluation process.
- Clinical evaluations are performed by qualified experts.
- The medical device manufacturer operates an effective process to evaluate the benefit risk ratio between performance of the product and implied risk.
Up to date Post Market and CAPA Processes
- The medical device manufacturer is compliant with all required post market processes according to MDR.
- The medical device manufacturer operates an effective CAPA process in order to ensure timely and appropriate handling of corrective and preventive actions.
- The medical device manufacturer operates an effective complaint management system to manage and evaluate complaints.
- The medical device manufacturer operates an effective vigilance and recall management system with a defined recall strategy.
