Quality Systems

• Registered quality management systems are often market entry requirements and provide your business with the level of credibility it truly deserves.
• We will work closely with your management team to develop smart ISO9001 / ISO13485 quality management systems. 
• Focussing on customer and business needs, but without compromising compliance.

To discuss quality systems call or email now

 

We provide excellent training packages which can be delivered where you want, whenever you need.

Training

• Understanding the Medical Device Regulations and what they mean to you
• The benefits of Understanding Quality Management Systems
• Audit Training & Assessment: A real Business Benefit
• Risk Management
• Statistical Process Control

All the above will be tailored to meet individual business demands.

If you have a training need call or email now

Device Classification

Classifying your devices correctly is an important issue, and getting this right is fundamental to downstream regulatory processes.

Med-Dev Consulting can help determine these classifications and develop the under supporting rationales and documentation.

To discuss device classification call or email now

Development of Technical Documentation / Design Dossiers

Med-Dev Consulting will work closely with you to develop technical documentation and construct technical files to confidently demonstrate your regulatory compliance.

Med-Dev Consulting will undertake independent review of documentation and dossiers prior to submission to regulatory authorities.

Risk Management

Med-Dev Consulting can implement system and process to manage the risks associated with products.  Develop appropriate quality plans to ensure customer safety.

Auditing

System Audits - Med-Dev Consulting will on request perform internal audits and independent supplier audits.

Product Audits - Med-Dev Consulting can undertake assignments to perform product audits in line with customer requirements and investigations.

Device Sterilisation and Microbiology

Med-Dev Consulting have significant experience in device sterilisation and microbiology , and can provide guidance on your validation programme.

Labelling

Med-Dev Consulting provide expert guidance and advice on labelling requirements.

Product Registration

Getting your product into the many and varied global markets is key to your success and business growth.  Med-Dev Consulting can help you access the many markets using our extensive international regulatory expertise.

EU representative Services

Foreign manufacturers selling products into the EU Countries are required to appoint an authorised representative in Europe.

Med-Dev Consulting can fulfil this important regulatory requirement on your behalf.

Due Diligence Services

Med-Dev Consulting can take on quality and regulatory due diligence assignments on your behalf.