Risk Analysis
Many customers ask us how to design a medical device according to standards. Too often it is thought that there is no answer to this question, but in reality the first step in designing a medical device in line with the regulatory standards is to draw up a detailed and applicable risk analysis. The risk analysis document is therefore the pivotal document in the certification process, i.e. the document in which the designer identifies all the technical solutions and all the standards to mitigate risks.
The drafting of the risk analysis cannot, therefore, be regarded as a marginal activity but must be carried out carefully, competently and professionally by a team of experts not only in the field of technology but also in the field of standards.
An improperly drafted risk analysis could have significant legal implications for the manufacturer as it is the document that is taken into account by the Certifying Bodies when obtaining certification and by the judicial authorities in the event of an accident or indication of a presumption of non-compliance.
AP Engineering supports manufacturers with a team of professionals who are experts in the field and in medical device standards to support the manufacturer in the correct drafting of the risk analysis according to EN 14971.
Do not wait for someone to challenge the conformity of your medical device or for the competent authority to delay the issuing of a certificate just because you have not performed a correct and thorough risk analysis taking into account all regulatory aspects. Call or contact AP Engineering for a timely risk analysis prepared by people with extensive experience, supported by participation in regulatory technical seminars.
Drafting of the technical file
The technical file of a medical device is to be understood as a set of technical documents describing all aspects that demonstrate the product's compliance with the safety requirements of the applicable regulations.
The difficulty in drawing up the technical file is knowing which documents must be drawn up and included in it. All too often, companies rely on people who are not competent in the regulatory field and this leads to potential risks, especially when submitting documentation to Notified Bodies for Certification.
AP Engineering through its staff, with consolidated experience and on the strength of its participation in regulatory working seminars, is able to support the customer not only in the composition of the technical file but also and above all in the drafting of the individual documents that make up the technical file.
The service offered by AP Engineering covers every possible requirement and in particular:
- Drafting of Risk Analysis.
- Drafting of Regulatory Requirements Analysis.
- Drafting of the documents analysing the certification process.
- Drafting of classification document.
- Drafting of biocompatibility analyses.
- Drafting, verification and validation of the usability plan.
- Drafting, verification and validation of the software.
- Drafting of other technical certification documents specifically required according to the type of medical device.
In addition, AP Engineering's highly professional service includes the possibility of providing support to the customer for numerous additional aspects such as:
- Management and performance of laboratory tests necessary to demonstrate compliance.
- Gap analysis legislation.
- Management and relations with the Notified Body.
- Management of the clinical validation process.
- Certification Accountability Service as prescribed by MDR.
- Preparation, drafting and control with periodic audits of the company's management system.
Our technical staff will support the customer throughout the entire certification process with a service that is divided into consolidated phases that allow certification to be achieved within the timeframe and in the manner specified in the agreed development plan, including:
- Analysis of specifications.
- Definition of the document and development plan.
- Support for the drafting of all documents.
- Laboratory tests.
- Contact and management of the certification file with the Certification Bodies.
If you need specialised technical support for medical devices, call or contact AP Engineering to arrange a meeting and define our support together to achieve your goal.
MDR Regulation 745/2017
On 26 May 2021, the new Medical Device Regulation came into force, which represents a major evolution from the previous Directive 93/42/EC. There are many changes with a major impact on the market and products.
The new classification rules, the new requirements for clinical validation, the new specifications for surveillance and the figure of the Certification Manager represent novelties with a strong impact on medical products.
AP Engineering through its staff, with consolidated experience and on the strength of its participation in regulatory working seminars, is able to support the customer in facing the new change with a quality and professional service that accompanies the customer to full compliance with the new requirements.
Our technical staff will support the customer throughout the entire certification process with a service that is divided into consolidated phases that allow certification to be achieved within the timeframe and in the manner specified in the agreed development plan, including:
- Analysis of specifications.
- Definition of the document and development plan.
- Support for the drafting and/or updating of all documents and the technical file.
- Laboratory tests.
- Contact and management of the certification file with the Certification Bodies.
The new regulation requires a high degree of professionalism to ensure compliance with the timeframe, as the non-conformities that can be detected by the Notified Body are, as a rule, many and specific.
If you need specialised technical support with regards MDR that guarantees you time and cost certainty, call or contact AP Engineering to arrange a meeting and define our support together to achieve your goal.