ISO 13485:2016 consultancy

  • ISO 13485 certification
  • Easy to use ProActive ISO 13485 QMS
  • Increased market access
  • Increased efficiencies
  • ISO 13485 certification
  • Easy to use ProActive ISO 13485 QMS
  • Increased market access
  • Increased efficiencies

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 confidence for interested parties in medical device quality conformity.

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 robust to provide confidence to your ISO assessor that the clauses of the quality management standard are being rigorously complied with by your business.

If your company has decided to implement ISO 13485:2016 you might be considering bringing in a consultant to assist with the implementation process.

DAT Performance can assist your company to build a first class medical device quality system that will both lead to 13485 ISO certification and added genuine value. Whether 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. These combined with the enthusiasm of your team help to place your business and customer recognition for its medical devices where it belongs.


ISO 13485 certification benefits include:

  • Access to new markets
  • Certification to an internationally recognised quality standard
  • Creation of competitive advantage
  • Conformity to regulatory requirements
  • Technical file conformity and CE product marking
  • Reduced levels of process risk
  • Technical excellence
  • Reduced waste


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ISO 13485 Consultants  

ISO 13485:2016 consultancy offers vary considerably for quality, value, cost and effectiveness. Making the right consultant selection will mean that you will soon begin to see a return on your investment through results.

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

Our ISO 13485 consultants are experts in the delivery of an effective QMS. During the 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 defined 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



ProActive ISO 13485 Software

Software making ISO 13485:2016 certification cost effective and easy!

Making the entire process of ISO 13485 certification cost effective and easy - ProActive compliance software.

ProActive is easily accessible from your desktop or remotely from your mobile devices.

In the office, on the shop-floor or at remote off-site locations ProActive provides rapid access to your vital ISO 13485 systems.

Unmatched for its array of software features ProActive provides significantly higher value when compared with other software packages.

Following initial ISO project commencement, using your ProActive action log your business will rapidly benefit from a quality management system that is both easy to use and effective.

The following ISO 13485 benefits are routinely enjoyed by ProActive software users:

  1. Reduced waste, increased productivity
  2. Easy to use ProActive ISO 13485 QMS
  3. Increased levels of customer / client satisfaction
  4. Medical device acceptance Class I, IIa, IIb, or III
  5. Improved financial returns through reduced failure costs
  6. Effective objectives and key performance indicators (KPIs)
  7. Globally recognised quality systems ISO 13458:2016 certification
  8. Raised quality awareness, problem-solving culture enhanced
  9. Improvement through established plan do check act methodologies
  10. Application of “risk based thinking” effective processes and process control measures
  11. Easy to use documentation and evidence of effective process controls
  12. Standardisation uniformity and increased predictability
  13. Easy integration with other standards i.e. ISO 9001, ISO 14001, ISO 45001, ISO 27001 etc
  14. Market entry barrier removal where ISO 13485:2016 is a pre-qualification requirement
  15. Confidence in medical device quality


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Head Office - Bingley, West Yorkshire