Consulting by CRC
We have been focused for years on recognizing complex relationships and describing complicated matters clearly and understandably. We analyze the structures in your company and compare them with the state of the art and regulatory requirements. Taking into account our extensive experience, we find pragmatic solutions that fit your business.
Management systems
We support you in the implementation of management systems in your organization. In addition to ISO 9001, the introduction of quality management systems for medical device manufacturers based on ISO 13485 is a key focus of our consulting services. This also includes meeting the requirements of QSR 820.
We also meet the growing demands for cybersecurity and information security and are happy to assist you in the implementation of ISO 27001 information security management systems.
Additionally, there is experience in the field of accreditation of testing laboratories based on ISO 17025.
A quality management system is the implementation of the normatively required standards of ISO 9001 within the organization. The goal of a quality management system is to achieve continuous improvement in the organization through adherence to standards.
We assist you in the establishment, implementation, and maintenance of these standards in your company. Our goal is to create a system with you that is lived within the company and adds value.
ISO 27001 is an international standard for information security management systems that enables organizations to reliably implement all requirements for data protection and information security. It follows the same principles that quality management systems, such as ISO 9001, adhere to.
The implementation of ISO 27001 offers numerous benefits, such as the ability to identify and prevent threats to information security early on, continuous improvement of the quality of information security processes, and protection of confidential and personal (customer) data from misuse or loss.
We implement regulatory-required quality management systems with you in your organization, aiming to ensure the safety of patients and users of your medical devices, thereby securing your market access eligibility. The implementation follows the requirements of ISO 13485. Extensive experience from FDA inspections helps to pragmatically implement and meet the requirements of QSR 820 for access to the US market.
The ISO 17025 provides the normative basis for the accreditation of testing laboratories. Benefit from our experience in implementing 17025 in testing laboratories in the fields of electrical safety and laboratory diagnostics.
Process development / optimization
We help to specifically eliminate vulnerabilities in your system and close compliance gaps. In particular, processes related to the topics
- Risk management according to ISO 14971
- Development process according to ISO 62304 and ISO 82304
- Usability process ISO 62366
- CAPA and Change Control according to ISO 13485 and QSR 820
- Vigilance systems according to MDR
- Medical Device Reporting according to 21 CFR Part 803
- GMP / GDP / GXP
- Hygiene Monitoring / Pest Control
must be tailored to your organization, sensibly structured, and interconnected. Leverage the expertise of our specialists and transform the regulatory processes required into a valuable contribution to the safety of your products and the success of your company.
The risk management process according to ISO 14971 already provides input for the technical documentation for CE marking during development, as well as for the risk-based requirements of ISO 13485. Implementing the process sensibly while considering these interfaces is the essential foundation for safe products and efficient processes.
The usability of medical devices is, in our view, a key function of medical products. We support you in implementing the requirements of ISO 62366 in your development process and assist with our extensive network in conducting usability tests. Our goal is to demonstrate that your products are usable for users and patients.
The ISO 62304 and ISO 82304 include requirements for the development processes of software intended for medical purposes. We implement streamlined and practical processes together with your development engineers that meet these standard requirements. In doing so, we ensure the appropriate integration with the risk management process.
In the production of medical devices in hygienically controlled areas, it is essential to appropriately manage environmental conditions and establish processes that maintain these environmental conditions consistently over time.
We explain why efforts are made to catch pests in cleanrooms and assist in the development of hygiene plans.
We implement regulatory-required processes together with you regarding market surveillance and reporting related to incidents of medical devices in the market.
In doing so, we take into account all the requirements of the MDR for products on the European market, such as PMS plans and Periodic Safety Update Reports, as well as the requirements under 21 CFR Part 803 for products on the US market.
TROUBLESHOOTING / GAP ANALYSIS / INTERNAL AUDIT
As one of our core competencies, we see the preparation of process deviations. We work with you to develop collaborative and pragmatic solutions in preparation for FDA inspections and external audits, including their accompaniment and follow-up.
We contribute to increasing the compliance of your systems by conducting internal audits, thereby creating inspection and audit security.
We support you in the analysis and resolution of regulatory deviations. The deficiencies are analyzed considering the affected interfaces. Based on our experience, we will work with you to develop a plan that reliably eliminates the deviations. Our team is happy to take on defined work packages to close gaps before they can cause harm.
Our experience from supporting numerous audits helps you prepare effectively for upcoming audits and regulatory inspections. This way, deviations can be identified and addressed in advance if necessary. Many deviations result from misunderstandings between the organization and the auditor. For complex issues, a coherent history can be developed, and its communication (in regulatory wording) can be trained with your employees. Should audit deviations arise, we assist in the appropriate handling to prevent a potential withdrawal of certification. If an audit entails larger tasks, we can support you with our team in the timely resolution of the deviations.
Our experience from supporting numerous FDA inspections helps you prepare effectively for upcoming inspections. This allows deviations to be identified and addressed in advance if necessary. Many deviations result from misunderstandings between the organization and the auditor. For complex issues, a coherent history can be developed, and its communication (in regulatory wording) can be trained with your employees. The success of inspections largely depends on the organization of the inspection. Keeping track of active requested documents and only providing pre-reviewed audit evidence in the front room significantly influences the outcome of an inspection. Should deviations arise, we assist in formulating an appropriate response to a 483, thereby avoiding the issuance of a Warning Letter. If an inspection leads to larger tasks, we can support you with our team in the timely handling of the deviations.
We identify deviations before external auditors do! If internal audits are conducted in a timely manner, there is enough time to plan the resolution of deviations effectively and to carry out the necessary work in a relaxed and sustainable manner. With our competent team, we can cover a wide scope of regulatory requirements. In addition to our core competencies in ISO 13485, ISO 9001, ISO 62304, MDR, and ISO 14971, the requirements of ISO 50001 and ISO 45001 are also applied in the conduct of internal audits.