SERVICES
No two companies or products require the same services and therefore MDM provides a comprehensive service tailored to your specific needs.
Our services include implementing Quality Management Systems (QMS) based on ISO 13485 integrating the geographic regulatory requirements of your choice.
We can assist in documenting Technical Files or Design Dossiers to meet the requirements of the European Medical Device Directive or FDA 510(k) applications.
For manufacturers located outside of the European Community we offer EC Representative Services.
We can support your design process or provide design expertise and audit potential suppliers.
MDM provides integrated flowchart based systems which efficiently guide you through the ever growing worldwide maze of quality and regulatory issues.
The systems are based on ISO 13485 and integrate the quality requirements of the geographic region(s) in which you wish to sell your devices. For example this may require the specific requirements for the:
European Medical Device Directive
ANVISA for Brazil
21 CFR Part 820 for the USA
PAL for Japan
Health Canada
Or other areas to meet your requirements
We make extensive use of flow charts creating a user friendly system which can be easily updated to meet the growing needs of your company and the changing requirements of standards and legislation.
We can integrate the requirements of other standards such as:
• IEC 27001 for information security
• IEC 62304 for software lifecycle
• IEC 62366 for usability
• ISO 14971 for risk assessment
• ISO 11135 for sterilisation of health care products by Ethylene oxide
• ISO 11137 for sterilisation of health care products by Radiation
• ISO 17665 for sterilisation of health care products by moist heat
• ISO 13408 for aseptic processing of health care products
• ISO 14644 for cleanroom implementation and operation
And many others.
Having implemented the system we can undertake internal audits, conduct management reviews and support you through your assessment by a Notified Body or other National Regulatory compliance agency
The range of requirements is varied and is dependent on the type of product and the market. MDM would be pleased to assess your specific requirements and support you from innovation to production and beyond.
Quality Systems
Regulatory Compliance
We can identify the classification region by region and determine the documentation required for your device in a specific region.
We can assist in documenting Technical Files or Design Dossiers to meet the requirements of the European Medical Device Directive,FDA 510(k) and other regional applications.
For clients who do not have appropriate data available we can offer or arrange for testing services ranging from accelerated ageing to Electro Magnetic Compatibility (EMC) to ISO 60601-1-2. For sterile products we can assist with validation of the sterilisation process.
We can offer EC Representative Services for manufacturers located outside of the European Community.
The range of requirements is varied and is dependent on the type of product and the market. MDM would be pleased to assess your specific requirements and support you from innovation to production and beyond.
Working with you to achieve regulatory compliance around the world
Support Services
For clients who do not have appropriate data available to meet regulatory requirements we can offer or arrange for testing services.
All electrical devices require to meet the regional Electro Magnetic Compatibility requirements, through a strategic partner MDM can offer UKAS accredited testing to meet the requirements of ISO 60601-1-2.
MDM conduct accelerated ageing and real time ageing tests for clients relating to the performance of both the packaging and the product.
For sterile and aseptic products we are able to manage or oversee the process validation to:
• ISO 11135 for sterilisation of health care products by Ethylene oxide
• ISO 11137 for sterilisation of health care products by Radiation
• ISO 14644 for cleanroom implementation and operation
• ISO 17665 for sterilisation of health care products by moist heat
• ISO 13408 for aseptic processing of health care products
We also conduct Quality Control and product batch release tests for clients who operate as virtual companies.
QUALITY SYSTEMS
REGULATORY COMPLIANCE
SUPPORT SERVICES
Medical Device Management Ltd
31 Braintree Business Park
Blackwell Drive, Braintree
Essex, CM7 2PU, UK
T: +44 (0)1376 342 303
F: +44 (0)1376 342 304
E: marketing@medicaldevicemanagement.com
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