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ISO 13485:2016 consultancy

  • ISO 13485 certification
  • Easy to use ISO 13485 QMS
  • Increased market access
  • MHRA device registration 
  • ISO 13485 certification
  • Easy to use ISO 13485 QMS
  • Increased market access
  • MHRA device registration 

Medical Device ISO 13485 Quality Systems Consultancy

ISO 13485:2016 is the international quality management standard for medical devices.

Class IIa, IIb, and III Medical device manufacturers who sell products within the UK and EU must apply controls as part of a formal ISO 13485 quality management system. Class I medical devices are associated with the lowest level of risk while class III medical devices are associated with the highest level of risk. ISO 13485 certification provides interested party confidence and assurance of medical device quality.

Conformity with and ultimately certification against ISO 13485:2016 includes the effective implementation of quality procedures and records including technical files. These must be sufficiently comprehensive and robust then evidenced to your ISO assessor for conformity to ISO 13485 and applicable device related regulatory requirements.

If your organization is committed to ISO 13485 implementation you might be consider engaging a consultant to assist with the implementation process.

DAT Performance frequently assists organizations like yours to build a first class medical device quality system that always result in ISO 13485 certification and improved performance. Whether you are starting from ground zero with nothing in place or at the point from where your system requires refining and preparing for certification we can help! 

DAT possess the consultants and tools required to get the job done, including our cost effective ISO management software, ProActive. Combined with the enthusiasm of your team our services help to provide improved recognition for both your organization and its medical devices.

ISO 13485 certification benefits include:

  • Access to new markets
  • MHRA compliance and registration 
  • Certification to an internationally recognised quality standard
  • Competitive advantage
  • Conformity to regulatory requirements
  • Technical file conformity UKCA and CE product marking
  • Improved processes
  • Reduced levels of process risk
  • Technical excellence
  • Repeat business

ISO 13485 consultancy and ProActive ISO compliance software

  • Click the VISIT PROACTIVEQMS button to access ISO 13485 compliance software offers
  • Scroll down to request your ISO 13485 consultancy quote

 

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ISO 13485 consultants Our ISO 13485 Certification Guarantee

ISO 13485 Consultants  

Great ISO 13485 consultants differentiate themselves through skill, real life experience and competences developed across various business sectors, medical device classifications and challenging situations. They possess the ability to adapt to the variable demands often presented by the MHRA, client requirements, process requirements, risk issues, customer requirements, interested parties and associated products and services.

Our ISO 13485 consultants are experts in the delivery of effective medical devices quality systems. During your quality system build your ISO 13485 consultant will coach and encourage your team, enabling them to get the most out of your new medical device quality system.

Services provided by our ISO consultants are characterised by the following;

1. Qualifications, experience, and a proven track record in effective ISO 13485:2016 implementation

2. Persistent in the pursuit of client improvement objectives

3. Good listening skills - listens first, talks later

4. Can get new and innovative ideas across to the client

5. Collaborative leadership style when providing ISO 13485 advice, able to integrate with the client's team

6. Flexible and adaptable when faced with challenging situations

7. Skilled in the application of problem solving techniques

8. Able to demonstrate the benefits of effective root cause analysis

9. Qualified ISO 13485 systems implementer

10. Proficient in “risk based thinking” and able demonstrate “risk based approaches"

11. A team player able to generate enthusiasm amongst the client team

12. Always learning and seeking improved ways of doing things

 

 

Our ISO 13485 Certification Guarantee

We have a 100% first time client certification record for ISO 13485 

Providing your team is fully committed to medical device quality, capable and enthusiastic, ISO 13485 certification is guaranteed using our combined consultancy and ProActive services.

Request your quote today

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Offices throughout the UK

Head Office - Bingley, West Yorkshire 

+44 (0) 1535 666984
info@isomadeeasy.com