Inspection readiness is the positive title, the glass is half full or half empty. Our experience is that most organizations are not ready for a serious inspection. The upcoming ISO 13485 / riskmanagement / FDA’s right to inspect your internal audits and supplier audits / management review reports / requirements will put more presure on your readiness!
We can help, start as soon as possible.
Interested?
Does your drug device combination product marketing authorization dossier include the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements (GSPRs) set out in Annex I of the MDR or the relevant device certificate issued by a notified body (NB) allowing the manufacturer to affix a CE marking to the medical device? Then you are good to go. You can establish this yourself but we can also be of help. If not, a NB is required in accordance with Article 117 the MDR to provide an opinion (NBOp) on the conformity of the device part with the relevant GSPRs.
We can assist you to lodge an application with a notified body designated in accordance with the MDR for the type of device in question. For this a letter is needed explaining of what is being requested and why.
The NB will reply by sending a contract which we will discuss. By returning a signed assessment contract the notified body is authorized to carry out the NBOp.
We take the lead in writing / compiling the Technical Documentation (TD), i.e. the objective evidence to demonstrate compliance. The 10 parts of the TD must be written in a language agreed with the notified body.
Interested? Other Regulatory issues?
The process-based approach could be a concern for those used to QSR and cGMP. With increased reference to “organizational” context, management systems should be linked to the strategic direction of the business. This means an organization has to align all its processes effectively. Our experience on the process approach can be valuable to you.
Organizations have to define the number and types of processes needed to fulfil their business object. While these will be unique to each organization, typical processes can be identified: processes for the management of an organization, managing resources, operational processes and measurement, analysis and improvement processes.
A process-based system normally consists of a high level, one page description of the business process model, for example a process flow chart in the quality system manual. This is supported by each of the processes being defined at the next level of detail, in procedures or work instructions used to define how certain tasks are carried out at each stage in the process.
We can help you with the key in this approach: establish (1) process inputs and outputs, (2) process sequence and interaction, (3) process risks and opportunities, (4) effective process operation and control. Also (5) make resources available, (6) allocate responsibilities and authorities, (7) monitor, analyze and review process, (8) implement actions necessary to achieve planned results and maintain the effectiveness of these processes. In case of process change determine impact on the QMS and on the combination products. Identify and list Quality Records.
Internal auditing has always been a corner stone in quality management. Changing to the 13485:2016 process system ads a new dimension: process auditing.
Learn, pass the exam and practicee our very structured process auditing methodology and create a safe haven for any external audit. Start with our 2 day training.
With the full compliance target, you will be proud to show any external auditor your impressive internal audit records.
To be used for: 21CFR part 4 (+13485:2016, EU/US cGMP, GDP, supplier audits and more….)
The adoption of 13485:2016 in the new QMSR implies full adoption of 14971:2019. Full stop (never fight the auditor on this subject)! Learn how to selectively apply 14971 and other methods……
And FMEA? This is a good risk prioritization method for certain processes, like the design process and more. Learn how and were to apply different risk management methods (e.g. IEC 62366-1 for user risks management).
In all cases you need a professional training in application of 14971:2019. We deliver this training with examination and certification.