Recently there have been numerous regulatory changes in the field of medical devices. To successfully implement new regulatory changes, it is advisable to carry out a GAP or delta audit before starting a project. This helps to define the project framework more precisely so you can better estimate the human resources and expertise required. Thus, as a supplier, manufacturer or intermediary you avoid the risk of suddenly having to stop production due to insufficient compliance.
What is this type of audit all about?
Basically, the actual status is closely examined with the envisaged target in relation to a regulation or standard and its differences or gaps (hence GAP audit) are identified leading to measures to be initiated to close these gaps. The alternative name “delta audit” refers to the term "difference" stemming from mathematics. The difference between “what is” and “what should be” is the “delta”. With a GAP or Delta Audit, you therefore receive specific information about the processes in need to be adapted or improved when compared to a specific requirement. NEMIUS is happy to support you in this process.
The usual procedure usually includes the following points:
- Preliminary discussion to clarify the objectives of the delta audit.
- Process analysis: Examination of the status
- Comparison of the analysis with the target state, identification of gaps
- Proposals for measures for change
- Implementation of the measures and completion of the GAP audit with an audit report
The opportunity for a full assessment through a GAP audit
Some medical device manufacturers did not have enough time in their daily business to deal intensively with the changes from the Medical Devices Act (MPG) to the Medical Devices Implementation Act (MPDG). Now the changes are binding, and production must be converted.
To close this gap as quickly as possible, a GAP or delta audit is particularly recommended. In addition, you should note that there are legal consequences for marketing medical devices WITHOUT valid certifications or complete documentation.
Of course, besides the actual aim of adapting to the changed legal framework there is a positive side effect. A GAP audit / Delta-audit can reveal hidden deficiencies, point out measures to increase efficiency and questions you when sticking to outdated practices. An external view from the outside is particularly valuable here. At NEMIUS, we have expert knowledge to conduct a GAP audit / Delta audit in your company. Our expertise will provide you with new impulses for your entire area and a comprehensible, functional, and efficient plan for the further development of your company.
Do not hesitate to contact us if you have any questions. We are at your disposal to support you in carrying out a GAP audit or Delta audit.
