We call ourselves "Experts in Certification"
Because we, as MEDAGENT, can draw on about 20 years of experience in the certification of quality management systems. Although we are not an accredited certification company, we will certainly help and advise you on your way to a QM certificate.
Our focus lies in...
Our consulting services in the area of quality management range from the implementation and maintenance of the QM system to its revision in case of upcoming changes of laws, standards or regulations. And if you simply need resources on a temporary basis, you’ve come to the right place.
The conformity of your processes offers the possibility to be competitive in the long run. With the help of an intact QM system you can create clear and transparent processes within the company, therefore increasing profitability, minimizing errors and thus lowering the entrepreneurial risk and increasing customer satisfaction and employee motivation in the long term.
Certification of your Quality system
Together with our team, we will put you on the right track or, if necessary, set additional course so that the goal of conformity with a wide range of normative and legal requirements can be achieved.
Our main focus lies in medical technology and the associated European standard, DIN ISO 13485. Of course, comparable internationally applicable regulations are no challenge for us. These include in particular the 21 CFR Part 820 (USA) and Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 3 (Australia), RDC ANVISA n. 16/2013 (Brazil) or MHLW Ministerial Ordinance No.169 (Japan).
Due to our proximity to small and medium-sized companies, we also have further cross-industry experience, based on EN ISO 9001.
What certification does not mean however...
A certification is not based on a rigid corset of rules, which constricts the company for the next years. Rather, it is an essential component of the company’s success and helps to react agilely to market changes. Due to the progressive dynamics of the markets, the requirements for medical products in terms of safety, quality and also customer satisfaction are developing ever faster. For this reason we believe that the most important characteristic of a good quality management system is the flexible reaction to changes. In order to optimally control the quality of the product, the flexibility of the processes and production sequences is of fundamental importance.
With our help and support you lay the foundation for this necessary flexibility as well as for the associated passing of your audit and for the timely marketing of your medical devices.
No matter in which European or international market you want to sell or market your medical device – an internal audit is the first step to check to what extent your products and processes comply with national standards and laws for medical devices.
In order to be able to sell your medical device on the European market, you as a manufacturer must undergo a conformity assessment procedure. As an essential part of the conformity assessment procedure, manufacturers of medical devices must submit technical documentation to a Notified Body. Based on this documentation, the Notified Bodies audit the compliance with basic safety and performance requirements and thus the marketability of the medical device.
In addition to the technical documentation, the legal manufacturer must introduce a quality management system that also meets the requirements of the Medical Device Directive or the Medical Device Directive and is reviewed by the auditors.
But even if you are not a manufacturer within the meaning of the Medical Devices Ordinance, but rather a contract manufacturer and extended workbench producing to customer specifications, the best way to ensure compliance with the normative and customer requirements is through an internal audit.
This is how we support you within the scope of an internal audit:
1. preliminary talk
As a manufacturer of medical devices, you have developed a new product and would like to have it approved for the market? Or is an existing product due for a new audit? Or perhaps you are a legal manufacturer of medical devices and would like to introduce a quality management system or improve an existing one? Perhaps you are nevertheless active as an extended workbench due to your core competence and would like to certify your QM system?
During this first free preliminary talk we will clarify exactly these questions. We create the basis for our cooperation and discuss all project steps that are important for achieving our common goal.
2. Internal Audit/GAP-Analysis
Following the preliminary discussion, we will put together an individual team to support you on your way to certification. In order to identify the status quo of the Quality system in your company, we will conduct an initial internal audit at your company based on the required audit criteria. If you have not yet implemented a QM system, a first step could be the development of a project plan or various workshops.
In this step we would like to find out and assess where your company stands and which requirements and regulations you meet in detail. On the basis of the results of this as-is analysis, we identify weaknesses as well as potential for improvement and thus determine the future need for action.
of a Quality system/adaptation of an existing system
Either we support you now with our many years of experience in defining your goals and the subsequent implementation of a standard-compliant QM system, or we work with you to adapt and further develop existing quality management processes so that practice-oriented and standard-compliant processes are created in your company and the deviations discovered in the audit are eliminated.
With the help of the written report, you are optimally prepared for the actual inspection by the Notified Body or Certification Body.
During the following external audit, we will of course also be there to support you. Thanks to our many years of expertise, we can almost always offer you a suitable answer to any question.
In an external audit, you can withstand the comprehensive review and meet all the necessary standard requirements that are placed on your quality management system to be certified. – This is our common goal.
Our consultants do not accompany you as “watchdogs”, but as coaches and supporters. Our claim is to accompany you properly and professionally. For this purpose, we use our holistic view of your company. We would like to support you in driving your company forward and answer the questions of the auditors together with you so that you pass the certification audit
The audit is followed by a joint review of the audit results. If necessary, we support you afterwards in the cause analysis, that has to be carried out, and in corrective measures. Finally, we will conduct an effectiveness review of the corrective measures carried out, so that you are well prepared for the future.
“MDSAP” stands for Medical Device Single Audit Program and is, in times of globalization and internationalization, a useful combination of regulatory requirements of Europe, USA, Canada, Brazil, Japan and Australia to standardize the approval process of medical devices as well as the associated conformity assessments and necessary audits.
Through our offices in the USA and Brazil, we have already gained years of experience in conducting inspections by the FDA or ANVISA.
Our team will assist you in implementing the country-specific requirements resulting from the MDSAP. From the first GAP analysis, through the implementation with your colleagues and employees to continuous further development. We are also happy to be at your side during the four to five days on-site audit by the Notified Body.