For companies operating in the medical device market, the implementation of a robust Quality Management System (QMS) is a key element to ensure compliance with the existing regulations,directives and the Regulation 2017/745.
In several countries (i.e. Europe, USA, Canada, Australia, Japan, China, and Taiwan), the product registration process requires conformity of the manufacturer’s Quality System, especially when medium- or high-risk products are involved.
In Europe, ISO 13485 is considered to be the de facto quality management standard for the medical device industry. In fact, the ISO 13485 certification is mandatory for most Class IIa, IIb, III medical devices and IVDs. ISO 13485 is also valid in other countries.
The new ISO 13485:2016 has introduced some relevant changes, including the alignment to global regulatory standards, several additional requirements and a stricter risk management policy.
Whether you need to upgrade an existing Quality System or build a new one, Merc can help you through the whole process and make sure that you achieve compliance with the ISO 13485:2016 standard, as well as with any other international and country-specific regulations (MDR 2017/745, FDA QSR, MDSAP, CMDCAS, etc).
We will start by identifying the relevant standards for your company and will follow you during development and implementation of your QMS. The initial audit and gap analysis will determine the master plan for the final project. Our expert consultants will define a flexible and efficient QMS that will promote your long -term success on the medical device market.
After implementing your QMS, Merc will help you maintain its efficiency over time by keeping it up-to-date with the new international standards and regulations, as well as with any new processes and/or products within your company.
Merc’s activities include internal, supplier and pre-assessment auditing. We will develop custom audit plans not only for you and your company, but also for your suppliers and subcontractors, in order to verify that quality requirements are met at all levels. We can also conduct due diligence audits in case of internal reorganization, acquisition and/or merging.
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In December 2019, the third edition of the ISO 14971 standard - Application of risk management to medical devices has been published.
Merc can support you in the implementation of the new requirements of ISO 14971:2019 in your Management Quality System.
We can guide your company to compliance and certification according to several standards.
The Regulation 2017/745 defines the aspects to be included in a Quality Management System and introduces new requirements to be implemented in its QMS.
Merc Team will provide you a qualified support to adapt the organization’s Quality System to the requirements of the new Regulation.
A good Quality System is an opportunity for a company’s business, not an obstacle.
Merc will help you identify the mandatory standard for your company’s QS and will follow you during its development and implementation or update.
Once you have implemented your QS, Merc will continue to be your partner in maintaining its efficiency over time by keeping it up-to-date with the new international standards and regulations, as well as with any new processes and/or products within your company.
We can perform internal, supplier or pre-inspection audits in order to check the correct implementation of your Quality System according to your internal procedures, or to any standards/directives/regulations.