System Design and Implementation (ISO 13485:2016)

Let QCS review your current organisational structure and then develop and assist with the implementation of a fully certified management system for medical device manufacture. QCS has experience delivering these systems across a wide range of sectors.

QCS has an 8-stage approach to bringing your medical device management system to life. Our aim is always to bring to life a system that contributes towards real improvement in your organisation.

Our unique approach includes:

  • Gap Analysis: We capture what you already do, identify the gaps and then provide you with an easy to understand project plan that we can both work with.
  • System Documentation: We produce a policy, manual and essential procedures and records, in a style and format that fits your organisation. We shall ensure documents relating to the regulatory framework relevant to your product are fully up to date and in compliance with the latest requirements (such as technical files).
  • Procedures & Records: We identify and produce drafts of key procedures and documented information for you to use.
  • Registers: We produce electronic registers to ensure you log all your results in a systematic way to effect ease of analysis. Registers might include, for example, Corrective Actions, Risk assessments, FMEA, supplier information, complaints and vigilance records.
  • Implementation: Regular reviews makes sure that your project is on track and that the system is implemented into your business not your business into the system.
  • Awareness Training: We will design and deliver a tailor-made training course in your company so that everyone is aware of the system and how to use it. This will include elements of training on relevant regulations.
  • System Auditing: We can train you or your team or do your first round of audits for you.
  • Pre-Certification Assessment: A full independent system audit to ensure first time certification.

Call or email us today to see how our approach works and for us to provide you with a no-obligation quote.

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