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QiP GmbH
Struveweg 40
14974 Ludwigsfelde
phone: +49(0)3378 / 2055180
fax: +49(0)3378 / 2055182
info@qip-qm.com
www.qip-qm.com
Managing Director:
Frank Ruben
Alexander Maier

QiP - Quality in Progress - GmbH is your exclusive and competent partner for quality management and certification in various fields of activities: Life science, health, food and more. We are your quality management specialists – your strong, reliable partner for excellence consulting services in quality related themes. QiP stands for “Quality in Progress”, our fundamental business idea. Our expertise is dedicated to your success, supporting you with excellent know-how in a wide range of aspects, in particular in quality management and quality assurance as well as concerning other issues.
QiP GmbH was founded in Mai 2017 and has its registered office in Ludwigsfelde/Brandenburg. Managing directors are M.Econ. Frank Ruben and M.Eng. Alexander Maier. Head of QM is Dr. Ephrat Lahmer-Naim, PhD. Our experienced staff experts are from the fields of medical physics, clinical trials management, biotechnology and bioinformatics. Our specialists are certified quality auditors and quality management representatives (QMBs). All our permanent employees regularly attend further training courses.

Our clients are from the medical technology as well as from the biotechnology sector, pharmaceutical industry, life science and other quality oriented fields. Our clients treasure the competent services of our well-coordinated team. We develop quality management systems (QMS), conduct audits and represent our clients in front of audits and inspections. We support the market authorization as well as the certification processes. Among others, clinical trials, clinical evaluations, validations, risk management and project management belong to our core competencies.

1. Quality Management Systems (QMS)
• Development, certification and update, e. g. DIN EN ISO 9001, DIN EN ISO 13485, DIN ISO/IEC 27001, DIN EN ISO 17025, etc.
• Quality Management Representative (QMR/ QMB) - all tasks, e. g.
o Improvement and standardising QM and QA processes
o Supplier/ vendor evaluation
o Survey, assessment and evaluation of clients’ satisfaction
o Complaints management
o Supporting the management review process
o Review and adaptation of process descriptions, templates, technical documentation and authorisation related documentation
o Representation in front of clients and authorities regarding quality related themes and in the framework of audits, e. g. FDA inspection pursuant to 21 CFR 820, GMP Quality System Regulation
• Development and Updating QM Documents
o Quality Management Manual (QM-Manual, QMH)
o Quality policy, quality aims/ targets and quality guidelines
o Description of processes and process interactions
o Standard operating procedures (SOPs), templates, flow-charts, check lists and master documents
o QM documents and specifications, e. g. for manufacturing medical devices
o Graphics, schematic presentations and figures, e. g. for reporting, handling, behaviour and patterns
o Performance figures and indicators

2. Audits
• External audits, e. g. system audits, supplier/ vendor audits
• Internal audits
• Mock audits
• Co-monitoring
• Auditing documents, e. g. QM manual (QMH), technical documentation, medical devices authorisation documentation, etc.
• Auditing clinical studies, e. g. Trial Master File (TMF), study documents, on site

3. Development and Updating
• Clinical evaluations of medical devices, MEDDEV 2.7/1 rev 4.0 (06/2016)
• Market survey and analyses, searches
• CE documentation
• Master plans, overviews, assessments and appraisals
• Overseeing action plans/ corrective & preventive actions (CAPAs)

4. Validation
• Methods validations
• Process validations
• Verifications
• Device qualifications
• e. g. for the
o Manufacturing of medical devices, in particular in clean room (class 7)
o Library of macros (statistical programming)

5. Risk Management
• In particular for medical devices according to DIN EN ISO 14971
• Risk analysis, assessment and appraisal
• Risk control
• Process, product and construction (development) FMEA

6. Supporting the Market Authorisation of Medical Devices
• Medical devices - all classes, in particular class IIa and IIb
• Software, in particular classes B and C
• Design History File (DHF)
• Technical documentation for the purpose of the market authorisation approval (CE mark) after conducting clinical trials and clinical evaluation
• Providing input and supporting the preparation of clinical trials in the USA, e.g. Human Factor study, trials with new medical devices (prototype, without CE mark), etc.
• Check list according to DIN EN ISO 60601-01 "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance"
• Check list according to IEC 62304 "Medical device software – software life cycle"

… and more
• Organisation, conducting and follow-up of training courses
o in particular concerning quality related themes
o GxP: Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), etc.
o medical devices, anti-corruption, data safety, office security, etc.
• Project management of international multi-centre clinical trials/ studies, e. g.
o Pharmaceuticals, in particular phase I First in Man and Advanced Therapy Medicinal Products (ATMP, e. g. stem cells)
o Medical devices - all classes and In-Vitro Diagnostics (IVD)
o Other diagnostics and therapy forms
o Post-marketing-studies and clinical application observations
o in children, adolescents and adults
o Human factor studies

Our team offers a wide range of competences in various fields. The following list provides a brief impression of the broad professional qualification in our consulting enterprise:
• Auditors
o Quality auditor for quality management systems (DEKRA, 04.11.2015)
o Quality auditor (DEKRA, 27.04.2016)
• Quality management representative (QMB, DEKRA, 11.09.2015)
• Quality representative (TÜV Nord, 23.06.2015)
• Quality manager (TÜV Nord, 20.07.2015)
• Compliance Officer, EU Regulation 2017/745 MDR
• Data Protection Officer, EU Regulation 2016/679
• Occupational safety (BG RCI, 26.02.2010)
• Clinical Trial Manager (CTM M.Sc. 2006)
• Medical physicist, DGMP certification of qualification
• Specialist knowledge in radiation protection (actualized according to the German radiation protection (StrlSchV) and X-ray (RöV) ordinances 12.01.2017)

Your benefit
• Individual expert consulting, in particular regarding QM and QA issues
• Relief for your in-house departments
• Market oriented strengthening and consolidation in global field of activities
• Input: Our sound knowledge and broad spectrum of experience (quality management, medical devices, biotechnology, validation, qualification, project management)