Product Life Cycle Management / Quality Management

Benefit from our long-term experience in implementing efficient QM systems that meet your requirements:

• Development of a customized QM system according to
  • EN ISO 13485,
  • cGMP e.g. 21 CFR Part 820 (QSMR),
  • European medical device regulations (MDR and IVDR),
  • further requirements coming from international sets of rules, e.g. EN ISO 9001, EN 9100, EN ISO/IEC 27001,
• Implementation of all processes required for development, production and marketing,
• Training of the new QM system, adapted to the different user groups,
• Accompanying support for your employees during the introductory phase,
• Support with internal audits and management reviews,
• Support during certification or surveillance audits,
• Long-term support in establishing and optimizing your QM system and
• Support in the selection, qualification and monitoring of your distributors and suppliers at home and abroad.

We also support you in qualifying as a distributor and supplier and equip you with efficient QM systems that comply with the requirements:

• for distributors:
  establishment of an MDR-compliant (partial) QM system, which may also include non-European requirements, and
• for suppliers:
  Advice during introduction of a new QM system or the expansion of an existing one, e.g. from EN ISO 9001 or IATF 16949 to EN ISO 13485 or 21 CFR 820.

Changes to regulatory requirements are part of everyday life in the development, manufacture and approval of medical devices. Understanding the consequences quickly and processing them for the customer in an understandable and results-oriented manner is a familiar task for seleon’s consultants, which we implement quickly and efficiently.

We implement new processes for you or optimize existing ones:

• Preparation of a delta/gap analysis of existing processes to new/changed regulatory requirements,
• Design and implementation of the necessary new or modified processes or process elements,
• Adaptation of the associated process and QM-relevant documentation,
• Provision of traceability analyses for the process-related requirements from the applicable standards,
• Training of the new or modified processes,
• Coaching for external audits and
• Support in the implementation of potential improvements.

Our experienced consultants draw on the company’s own knowledge from the two other core areas of development and production of sophisticated medical technology as well as from numerous different projects carried out.

We support you with:

• Recording and analyzing your existing processes (consistency and logic, number of roles involved, interfaces, media breaks, etc.),
• Development of a new and efficient process model that considers all areas, disciplines, roles, project types and processes involved,
• Presentation of the new processes with modern visualization tools and
• Creation of lean and clear role-based and therefore person-neutral processes that fulfill all necessary regulatory requirements (e.g. CE, FDA).

Our in-depth expertise is based on the realization of numerous international development and manufacturing projects in medical technology. Our consulting services cover the entire product lifecycle management (PLM) process.

We support you with:

• Determining the efficiency potential of your PLM processes within structured interviews with your top performers,
• Analysis and evaluation of process and interface complexity and efficiency,
• Introduction, evaluation and optimization of key performance indicators (KPIs) in the entire PLM area,
• Analysis, evaluation and optimization of cost structures,
• Targeted implementation of measures to reduce rework,
• Optimization of your product portfolio through platform concepts, variant optimization and complexity reduction as well as
• Consulting and project support in the selection, configuration, introduction and optimization of software tools to support your PLM processes (ALM tools such as POLARION, Greenlight Guru, JIRA, Confluence, PDM tools, etc.) – see also our digitization section

Due to the increasing complexity of medical devices, the need for consistent and methodically prepared documentation (design control) is becoming ever greater. The FDA in particular, but also increasingly the notified bodies in Europe, are showing a growing tendency to reject incomplete or non-transparent approval documents.

Our approach is to create a closer fusion of device architecture and life cycle activities with the documents accompanying development.

We achieve this through a consistent layer model that makes use of the logical levels of the V-model and combines this with a modularization concept that provides a consistent document set for each subsystem of the medical device. The documents belonging to a subsystem are clearly displayed in a design control chart, which makes it much easier for you to carry out a successful audit.

Our experienced consultants ensure the long-term safety of your products:

• Risk management according to EN ISO 14971, DIN ISO 31000,
• Carrying out preliminary hazard analyses (PHA) on the basis of a functional analysis,
• substantiation of the medical risks with clinical data,
• Carrying out product-related risk analyses (design FMEA) for assemblies, products and systems,
• Carrying out process-related risk analyses (process FMEA) for the entire supply chain,
• Definition of the essential performance characteristics according to the IEC / EN 60601-1 family of standards,
• Conception of safety concepts and specifications (safety cases) and
• Creation of a security/safety-related architecture for PEMS and PESS.

We support you with usability engineering activities for your medical device according to the life cycle phase

• Creation of the Use Specification,
• Identification, documentation and handling of safety-relevant features and use errors,
• Identification, documentation and treatment of hazard-related use scenarios,
• Identification and documentation of the User Interface Specification,
• Planning, implementation and evaluation of formative evaluations and summative evaluations as well as
• Creation of the usability engineering file.

Our auditors bring external know-how to your company:

• Joint definition of the audit scope and the company units to be assessed and preparation of the audit schedule,
• Review and analysis of the documents / records provided on processes and products,
• Conducting audits to evaluate the effectiveness of the QM system and / or the technical documentation at the customer’s premises,
• Conducting supplier audits to ensure compliance with process specifications and the specified product quality and documentation,
• Evaluation of the root cause analyses, corrections and corrective measures carried out and
• Evaluation of the effectiveness of corrective and preventive measures.

Our consultants will prepare you and support you during audits and inspections:

• Joint review of the audit schedule with the client, formulation of change requests, if necessary,
• Review and analysis of the documents / records to be provided for processes and products,
• Carrying out a pre-audit / mock audit and preparing a gap analysis,
• Support in the elimination of possible existing deviations/gaps,
• Support / coaching during the external audit / inspection,
• Joint review of the audit report with the customer, formulation of change requests, if necessary,
• Support with the root cause analysis, corrections and corrective actions (CAPA) and
• Support for the effectiveness assessment of corrective and preventive actions (CAPA).

Our consultants will prepare you specifically for MDSAP audits:

• Perform mock audits using the same process based MDSAP audit model used by the approved auditing organizations,
• Identification of gaps in the MDSAP requirements and development of specific solutions to close the gaps,
• Coaching on the application of risk-based thinking,
• Development and review of MDSAP audit checklists,
• Comparison of your internal audits with the MDSAP process and
• Assessment of the proper registration of your products in the participating countries and fulfillment of the MDSAP reporting requirements