Regulatory 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: it is essential to be permanently up-to-date with regulatory requirements, to adapt product files and quality management in time, and to meet deadlines for documents and registrations to be submitted. Cost efficiency is an issue as well. From inspection readiness to audits, preparation of process and work instructions, 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.
Design and Optimization of Quality Management Systems
The best QM system is of no use if it is not put into practice. After all, the ability to adapt to continuously tightening regulatory requirements or more demanding customer requirements determines whether a QM system is established in the company in a sustainable and beneficial manner. Ultimately, reliability and lean compliance can save time, costs and thus resources!
When designing or optimizing a QM system, it is important to use a risk-based approach, the central means of ensuring product quality and simultaneously achieving regulatory compliance, to keep effort and thus costs within comprehensible and justifiable limits.
A clearly structured approach is required here: How are processes from development, production, CAPA, post-market surveillance or internal audit effectively implemented and to what level of detail must they be documented? Which requirements have to be met and how? The requirements for manufacturers and economic actors in the medical device industry are manifold: EU MDR, MPDG, FDA QSReg, ISO 13485, ISO 14971, etc.
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, QMS optimization and QMS remediation.
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, an action plan for implementing new regulations, customized training to establish the necessary knowlege, an optimized supplier management program for dealing with critical suppliers, professional complaint and risk management, or a coherent CAPA mitigating measures plan. Unerringly complying with the applicable regulations in a targeted manner is the key - no more and no less. Adapted to the needs of the customer.
Approval of Medical Devices Worldwide - Meeting Regulatory Requirements
gempex provide supports in 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 also if a registration of the products in for example Australia, Brazil, China, India, Japan, Canada, Mexico, Russia or Saudi Arabia is aimed at. gempex accompanies the entire approval process, provides support in the risk classification of products, clearly shows product regulatory requirements, ensures their successful fulfillment or consolidates knowledge within the company through targeted employee training.
EU MDR Compliance: Focus on the Product Life Cycle
Maintaining the ability to deliver is a challenge under the manifold and strict requirements of the EU MDR. Competent consultancy in advance and a structured approach to realization ensure success – specific interpretation and targeted implementation. With a focus on the entire product life cycle. For example, how can the responsibilities of the PRRC – Person Responsible for Regulatory Compliance – be fulfilled? What is the significance of risk management according to ISO 14971:2019? How to address the new post-market requirements? What must medical technology importers and distributors do to comply with the legal situation?
Implementing the EU-MDR means the practicable and specific interpretation of the requirements and adaptation of the QMS to the expanded demands. This ensures reliable compliance.
Extended Obligations for Distributors and Importers - Compliant Market Provision of Medical Devices
Distributors and importers are also explicitly entrusted with manifold obligations under the 2017 new EU legislation. The provision of products on the market is subject to detailed requirements. Among other things, there is an obligation for close communication among economic actors and with authorities. There is also an obligation to establish a reporting system, for example for non-conformities in medical devices.
At the same time, national regulations such as the new Medical Device Law Implementation Act or the Medical Device Operator Ordinance apply. They must also be observed when making products available on the market and are reviewed by the relevant authorities. This is a complex field that must be navigated with reliability.
gempex offers support around the compliant market provision of products and is specialized in evaluating and implementing regulatory requirements also for distributors and importers.
Facilitation and Savings Potential through MDSAP - Medical Device Single Audit Program
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.
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.
Inspection-Readiness – Passing Audits well Prepared
An audit by a notified body for (re)certification according to ISO 13485 or an inspection by the responsible national or international authority is coming up? Then this is the time to optimally prepare the quality management system, employees and all participants for the external audit. gempex provides 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 consultants attend the process, support during preparation and follow-up of audits and inspections and contribute the required current, practical experience. A GAP analysis or mock-up inspection in advance expose 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.
Supplier Management, Supplier Controls, Supplier Qualification
The organisation and design of the supply chain harbours tremendous potential savings, for example through process optimization 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 optimizations 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 dezigning 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.
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.
- 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
- Expertise on nationally and internationally approved products
- Experience with conducting national and international audits