The compliance requirements of the EU-MDR, US FDA QSReg et al (Quality System Regulations) and ANVISA are always being revised and keep getting stricter. This poses tremendous challenges for the Q&R team tasked with realising reliable quality management and meeting unchanged product approval deadlines. Cost efficiency is increasingly becoming an issue as well. From inspection readiness to process and work instructions, supplier control, software validation, QMS remediation or post market surveillance, the tasks are many and varied. Compliance and effectiveness have to be consistently assured. This is where gempex comes in with consultancy and support throughout the entire life cycle of medical devices. Competent, transparent, reliable.
Quality Management Systems and Product Regulatory Requirements
gempex provides support for all tasks related to the quality management system: QMS design and implementation, preparation of work and process instructions, design controls, CAPA management or QMS realignment, QMS optimisation and QMS remediation.
gempex is a partner of the medical technology industry with regard to product regulatory requirements as well. The medical devices specialists support with all questions regarding the approval of medical devices worldwide – no matter whether a conformity assessment according to EU MDR or a 510k approval at the US FDA is to be carried out. And even if a registration of the products in e. g. Australia, Brazil, China, India, Japan, Canada, Mexico, Russia or Saudi Arabia is desired, gempex is the right contact. Experienced consultants accompany the registration process, support e. g. with the risk classification of the products also, and consolidate the knowledge in the company through the provision of staff trainings.
Specific Needs as a Basis for Efficient Solutions
An exact determination of specific needs forms the basis for most projects. This can take the form of a gap analysis, scoping meeting or mock-up audit. What has to be done? What is not required? Tailor-made, individual solutions are subsequently developed, coordinated and established with an eye on cost effectiveness and day-to-day practicality. These range from a work package for inspection readiness to an action plan, adapted training, optimised supplier management program, effective complaint management or CAPA mitigating measures plan. Unerringly complying with the applicable regulations is the key – no more and no less. Tailored to the needs of the customer.
Inspection-Readiness – Passing Audits with Confidence and No Stress
An audit by a notified body for (re)certification according to ISO 13485:2016 or an inspection by the responsible national authority or an international regulatory authority is coming up? Then this is the time to optimally prepare the quality management system, employees and all participants for the external audit. In-depth knowledge of the respective requirements, expertise in conducting audits and inspections, and the know-how required for audit follow-up ensure success.
Experienced gempex consultants attend the process, provide support during preparation and follow-up and contribute the required current, practical experience. An advance GAP analysis or mock-up inspection exposes possible weaknesses. These are weighted and the required measures are defined and unerringly implemented. QMS documentation is a common issue. Or employee training. Or proper support for the regulatory authorities on site. On request, this audit/inspection preparation and follow-up full service also includes the handling of all communication with the authorities. Coordinated, transparent and competent.
Benefits, Relief, Potential Savings through MDSAP
MDSAP, the Medical Device Single Audit Program, was concluded between the USA, Canada, Brazil, Australia and Japan. It states that audits and inspections carried out by an MDSAP partner country are fully recognised by all other partner countries. Even for deliveries to just two of the aforementioned countries, this allows medical device manufacturers to realise tremendous relief and potential savings. However, five different sets of national requirements have to be taken into account.
gempex offers comprehensive support in preparing for an MDSAP audit and assists with both the execution and follow-up. The focus is on effectiveness and efficiency.
Supplier Management, Supplier Controls, Supplier Qualification
The organisation and design of the supply chain harbours tremendous potential savings, for example through process optimisation in the area of purchasing controls against the background of relevant regulations. Supplier management is a key factor in order to bring a compliant product to market in a timely manner or to establish optimisations in the existing product portfolio. Time and cost savings are realised when this is well thought out.
gempex assists with supplier qualification, conducts GAP analyses and audits of suppliers and distributors, identifies starting points for optimisation and helps implement these measures. They can range from designing a supplier audit program to preparing documents and work instructions to drafting quality assurance agreements. Supply chains are thereby optimised in view of compliance and cost effectiveness.
Training Standards & Regulations for Effective Compliance
The best QMS is useless if it is not applied reliably. This is where expertise brings reliability and ultimately also efficiency. New implementation or update – gempex develops and implements a Q&R training program tailored to the specific situation, on topics such as good documentation practices, front office/back office management, complaint management, inspection or audit preparation and also lead auditor training & qualification.
Individually aligned knowledge transfer is the benefit. On site at the customer facility or in the form of online seminars. All training concludes with the verification of success.
EU MDR Compliance: Focus on the Product Life Cycle
The manifold and strict requirements of the EU-MDR have to be met to ensure the ability to deliver. This is a challenge – the transition from the MDD is not always simple. Competent consultancy in advance and a structured approach to realisation – specific interpretation and targeted implementation – ensure success. With a focus on the entire product life cycle and with a sense of proportion. For example, how can the responsibilities of the PRRC – Person Responsible for Regulatory Compliance – be realised? What is the significance of risk management according to ISO 14971:2019?
Implementing the EU-MDR means the practical interpretation of the new requirement and adaptation of the QMS to the expanded demands. This ensures reliable compliance.
- Flexible support, detailed knowledge of the regulations
- Pragmatic, individually tailored solutions
- Effective implementation with an eye on cost effectiveness
- Industry experience and expertise in Q&R consultancy
- Compliance with the requirements of, for example, the EU MDR, MDSAP, US FDA QSReg et al, ANVISA
- Nationally and internationally approved products
- Experience with conducting national and international audits