Compliance and validation consulting for pharma, medical technology and biotechnology – practical and efficient.

Grünewald GmbH

Bensheim · HeppenheimNew on Amplifa

1999Founded

nearly 40Employees (2023)

2Locations

1,000 – 3,000,000 eurosProject volumes

About Grünewald

Grünewald GmbH is a consulting firm based in Bensheim that supports companies from the pharmaceutical, medical technology and biotechnology sectors with regulatory requirements. Its range of services covers regulatory compliance, quality management under ISO 13485, ISO 9001, EU-GMP and FDA 21 CFR 820, risk management under ISO 14971, qualification and validation of facilities and processes, GMP facility relocations, computer system validation (CSV), cybersecurity for medical devices, audits as well as market access. The team of nearly 40 biologists, chemists, process engineers and scientists works in an interdisciplinary and project-oriented manner. Clients include start-ups, mid-sized companies and international corporations; project volumes range from 1,000 euros to over 3,000,000 euros. The company's own quality management system is certified under DIN EN ISO 13485:2016 (TÜV SÜD, certificate valid until 2027). Founded in 1999 in Heppenheim, the owner-managed company has been based in a new building in Bensheim since 2021.

Site: Bensheim
Processes: Regulatory Compliance, Quality Management (ISO 13485, ISO 9001, EU-GMP, FDA 21 CFR 820), Risk Management (ISO 14971, FMEA), Research and Development, Production and Logistics / Lean GMP Engineering, Market Access, Digital Compliance / CSV, Qualification and Validation
Materials: DIN EN ISO 13485:2016, DIN ISO 9001:2015, ISO 14971:2019, EU-GMP, EU-MDR (2017/745) / EU-IVDR (2017/746), FDA 21 CFR 820, IEC 81001-5-1:2021, Lean GMP Manufacturing
Certificates: ISO 13485:2016, ISO 13485:2016 (TÜV SÜD)
Founded: 1999
Employees: nearly 40 (2023)
Industries: Medical Technology, Biotechnology, Pharmaceutical Industry, Pharma

01
Requirements and gap analysis
02
Risk-based conception (e.g. ISO 14971, QbD)
03
Implementation of QM, validation and compliance projects
04
Documentation and lean evidence management
05
Audit support and continuous improvement

Standards and Methods

ISO 13485

DIN EN ISO 13485:2016

Standard for quality management systems of medical devices – the basis of the company's own certification and its consulting.

ISO 9001

DIN ISO 9001:2015

Basis of process-oriented quality management systems for regulated industries.

ISO 14971

ISO 14971:2019

Risk management for medical devices, among other things using the FMEA method.

EU-GMP

Guidelines for pharmaceutical quality systems, qualification and validation.

MDR/IVDR

EU-MDR (2017/745) / EU-IVDR (2017/746)

Regulatory requirements for medical devices and in-vitro diagnostics.

FDA 21 CFR 820

US QSR requirements for medical device manufacturers.

IEC 81001-5-1

IEC 81001-5-1:2021

State of the art for cybersecurity of health software across the product life cycle.

Lean/Kaizen

Lean GMP Manufacturing

Kaizen, 5S, value stream mapping and DoE for process optimization in GMP production.

Locations

Bensheim

Head office with office building (space for up to 80 employees)

Heppenheim

Founding location (historical)

Industries

Medical TechnologyBiotechnologyPharmaceutical IndustryPharma

Additional services

Regulatory ComplianceQuality Management (ISO 13485, ISO 9001, EU-GMP, FDA 21 CFR 820)Risk Management (ISO 14971, FMEA)Research and DevelopmentProduction and Logistics / Lean GMP EngineeringMarket AccessDigital Compliance / CSVQualification and ValidationGMP Facility RelocationAudits (1st/2nd Party, Supplier Audits)Interim QMRExpress ConsultingCybersecurity for Medical Devices

Reference customers

Start-upsMid-sized companiesInternational corporations (not named, confidentiality)

Quality

Grünewald GmbH's quality management system is certified under DIN EN ISO 13485:2016 by TÜV SÜD (certificate Q8 111131 0001 Rev. 01, valid until 07.12.2027). Internal audits, supplier audits and audit preparations are carried out by lead auditors certified under ISO 19011.

Evidence	Bensheim
ISO 13485:2016 (TÜV SÜD)

History

1999
Company founded by Jürgen Grünewald in Heppenheim, focusing on lean evidence management in the pharmaceutical industry (qualification/validation).
2001
Systematic establishment of a risk-based approach to validations in the pharmaceutical sector.
2004
Expansion of the service spectrum to include regulatory and normative requirements of the medical device industry.
2007
First risk-based approach applied to the relocation of regulated production areas during ongoing operations.
2012
Steady growth and relocation within Heppenheim.
2015
Expansion of the service spectrum to include normative and regulatory requirements of biotechnology.
2018
Acquisition by Szilárd Varga, renaming to Grünewald GmbH & Co KG.
2019
Renaming to Grünewald GmbH.
2020
Start of certification under DIN EN ISO 13485.
2021
New building and relocation to Bensheim; ISO 13485 certificate issued in December.
2023
Nearly 40 experts; preferred supplier for well-known companies and international corporations.