An audit is the most effective way to gain assurance that you as a manufacturer, supplier or distributor of medical devices that are able to meet all requirements.Metecon supports you comprehensively in this area with a great deal of experience and know-how. Get an overview of our services. And if you see a need, we look forward to hearing from you!
Probably the best known: ISO 13485:2021 - your proof that you provide medical devices and related services that meet customer requirements and applicable regulations.Test our expertise in a no-obligation initial consultation
Supplier Audits
As a supplier or subcontractor of products, e.g., components of medical devices, your client usually requires a certification of your company according to EN ISO 9001 or EN ISO 13485. In order to find out whether you meet all requirements, we conduct an internal audit at your company and can prevent deviations of your client or the certifying body. In this course we can also check the contractual regulations between you and your client (QSV). Contact us, we will be happy to advise you.You are located in the EU and import and/or trade with medical devices?
Then you are obligated since 26.05.2021 to fulfill the requirements of the European Medical Device Regulation (EU) 2017/745 (MDR) according to Article 13 and/or Article 14. You must perform tests on the product and on the information provided by the manufacturer. You can find out in detail which tests these are and how you must document them in our Blog post on this topic.
Management representative according to DIN EN ISO 13485
The Management Representative (MRO), as required by ISO 13485 - often known among manufacturers as the Quality Management Representative (QMR) - is an important role in a company. The management representative is appointed by the company's top management and is responsible for ensuring that a quality management system is implemented, documented and effectively maintained in accordance with ISO 13485. Through close communication with top management, the BdL ensures that the QMS is continuously improved and that its effectiveness is reported to management. Furthermore, the BdL is responsible for implementing applicable regulatory requirements within the company and ensuring their implementation.Can't find a suitable person for your company to fill the role of management representative(s)? Or you need a resource to fill the gap until your new QMR starts as an employee* in your company? Feel free to contact us about this - we will be happy to provide you with an interim QMR: we will support your company in the designated tasks to execute the effectiveness of the QMS and the requirement of ISO 13485 in a compliant manner at all times.
PRRC: the Person Responsible for Your Regulatory Compliance
The Person Responsible for Regulatory Compliance (PRRC) according to Article 15, MDR must be in place for every medical device manufacturer. However, there are exceptions:Are you a small or micro enterprise and economic operator as defined in the Medical Devices Regulation (EU) 2017/745 (MDR) and have fewer than 50 employees and an annual turnover or annual balance sheet total of no more than EUR 10 million, or fewer than 10 employees and an annual turnover or annual balance sheet total of no more than EUR 2 million?
If so, you are not required to have a person responsible for regulatory compliance available within your organization; however, you must have permanent and ongoing access to such a person.
How to find a qualified person who meets all the requirements of this responsible personBy contacting us and describing your concern.
Our services in this area
- Conducting audits and supplier assessments,
- Supporting our customers in external certification audits,
- Auditor activities, if an audit has to be performed at your site according to the requirements listed below:
- (EU) Regulation 2017/745IVDD 98/79/EC In-Vitro Diagnostic Directive,
- ISO 13485 Medical Devices - Quality Management Systems,
- ISO 9001 - Quality Management Systems - Requirements,
- AIMDD 90/385/EEC Active Implantable Medical Devices Directive,
- 21 CFR 820 Quality System Regulation,
- 21 CFR 210/211 cGMP,
- 21 CFR Part 4: Current Good Manufacturing Requirements for Combination Products,
- Canadian Medical Devices Regulation (CMDR): CAN/CSA ISO 13485 (CMDCAS),
- Australian Therapeutic Goods (Medical Devices) Regulations 2002.