Boosting Efficiency in Your Quality Management
Safety, Quality, and Compliance at Every Stage.
Your experts in ISO-compliant risk management.
Nicole Spilger
Compliance Specialist / Consultant
Optimizing Quality Management in MedTech & Pharma
Standardized templates with a supposed “audit guarantee” may look tempting at first glance. In practice, however, they often fail to achieve their goal, as complex processes in medical technology and pharmaceutical companies cannot be adequately represented with them.
We develop and optimize quality management systems together with our clients – practical, regulatory sound, and adapted to real processes. Whether as interim QMR, project lead or facilitator: we consistently take into account the requirements of ISO 13485, ISO 9001, GMP guidelines, MDR (EU 2017/745), IVDR (EU 2017/746), FDA 21 CFR 820 and other relevant standards. The focus is on effective, risk-based and lean processes that are regulatory compliant, leverage opportunities for improvement, and avoid unnecessary complexity.
Our clients from MedTech, Pharma and Biotech value open exchange at eye level. Thanks to many years of industry experience and close involvement of local teams, best practices have emerged that have proven sustainable in strictly regulated environments.
QMS according to ISO 13485
We combine our expertise in ISO 9001, ISO 13485 and FDA 21 CFR 820 with tailored consulting to ensure your real processes are mapped in a compliant way. With active employee involvement we support sustainable implementation and continuous improvement of an effective quality management system.
Process Visualisation and SOPs
With process visualisation we uncover targeted optimisation potential. Our specialists support concept development, facilitation, planning and documentation, including compliant procedures and practical SOPs. Workshops build shared understanding and deliver measurable improvements in daily operations.
Pharmaceutical Quality System
Although ISO 13485, ISO 9001 and EU GMP differ, key success factors are similar: clear communication, dedicated teams and the smart use of suitable tools. In pharmaceutical or combined product settings we help build a robust and compliant quality system in line with EU GMP.
Optimised Processes with Kaizen and 5S
Kaizen and 5S support continuous improvement beyond regulatory compliance. Our consultants use ISO TR 10017, Lean Management and Six Sigma to optimise processes in a structured, transparent and lasting way.
Confidently Through Audits, Inspections and Certifications with GRÜNEWALD
Certification audits, regulatory inspections and internal audits place high demands on companies in regulated industries. It is not only the QM documentation that is reviewed, but also whether defined processes are truly lived in daily operations. With process flowcharts, we present your processes clearly and transparently, uncovering optimisation potential.
Our GRÜNEWALD consultants provide targeted support in audit preparation: with gap analyses, proven best practices and structured team preparation. This enables you to master audits and inspections confidently and securely, whether for ISO 13485, FDA, GMP or other standards.
1st and 2nd Party Audits
Our experienced auditors support you during internal and external audits, identify optimisation opportunities and promote value adding, standards compliant quality management.
Audit Readiness for MDR and IVDR
We conduct structured gap analyses to verify compliance with MDR 2017/745 and IVDR 2017/746. With our project experience we develop practical, workable solutions.
Audit Preparation
Successful audit and inspection preparation means more than document checks. We support you with gap analysis, employee training, workshops, mock audits and coordination with authorities.
Supplier and Service Provider Audits
We bring extensive experience from client projects into your supplier and service provider audits. This makes external reviews efficient, conserves resources and ensures compliance requirements are reliably met.
Quality and Safety Through Tailored Audits
Our focus is on reliable performance and rapid issue resolution, with zero tolerance for patient and user risks.
We support QM officers and specialist departments in developing a vital QM system and perform in depth reviews of existing systems and work instructions. We prepare your team intensively for internal and external audits and assist in evaluating your current quality management system and developing improvement strategies. Our ISO 19011 certified lead auditors also conduct supplier audits or internal audits on your behalf.
Our GRÜNEWALD team can also act as interim Quality Management Representative (QMR), providing flexibility in staffing. We offer continuous on the job training, coaching and support for initial projects or audits.
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