Expert consulting.
Quality Management
Toxicology
Crisis Management
EU approvals
Quality Management and Quality Assurance
BIOSERV’s experienced quality experts support you in implementing or maintaining quality management concepts in accordance with the current requirements of national and international standards. As part of your quality assurance, we carry out company inspections and quality assurance measures for you. Whether you need regular support, preparation for upcoming external audits, conducting internal audits, support during audits or document preparation, we offer comprehensive solutions.
Our consultants are “higher level
Labelling Inspection
Compliance with national and international standards for product labelling is a complex area, with new regulations and directives coming into force all the time. Depending on the product category, there are numerous regulations for legal labelling. BIOSERV supports companies in the legally correct implementation, e.g. on the basis of the European Food Information Regulation (FIR, EU Regulation No. 1169/2011) or according to the EU Cosmetics Regulation (EC) No. 1223/2009. BIOSERV’s team of experts also provides support in the use of health claims and advertising statements.
BIOSERV offers labelling tests for the following regulations
HACCP approaches to food hygiene
Regulation (EC) No 852/2004 requires food business operators to establish, implement and maintain a HACCP system at all stages of production, processing and distribution. BIOSERV develops individual, pragmatic and lean HACCP concepts for all companies in the food industry and food trade that meet the applicable legal requirements. BIOSERV also checks that existing documents are correct and up to date and provides support in the event of official complaints, new developments and restructuring.
Who has to implement HACCP concepts?
Toxicological analyses, Expert opinions and assessments
The scientific analysis of health risks that may arise from exposure to harmful substances is an essential part of product development, approval or crisis management for a wide range of product groups. The risk may be caused by chemicals, leachables from products, residues or (microbial) contaminants.
BIOSERV’s experienced toxicologists and interdisciplinary team of scientists analyse individual problems and assess existing risks in the context of relevant standards and legal frameworks.
Biocompatibility assessment in accordance with DIN EN ISO 10993
The biological safety of a medical device is a key component of the regulatory assessment and approval process.
According to this standard and the EU Medical Device Regulation (MDR), every product must undergo testing for potential biological risks as part of the overall risk assessment.
Gap and risk analysis
We analyse existing data on materials and composition, as well as existing test results, to ensure they are complete and relevant. This allows us to identify potential data gaps and assess the biological risk of your product in terms of contact type, exposure duration and intended use, in accordance with DIN EN ISO 10993-1 requirements.
Biological evaluation plan (BEP) and evaluation report (BER)
Based on the risk analysis, we will create a BEP which specifies the necessary testing requirements and defines which biocompatibility tests are required. The result is a clear, comprehensible testing strategy that is efficient and compliant with standards. After completing the tests or evaluating existing data, we prepare the Biological Evaluation Report (BER). This report provides a scientifically sound assessment of the biological safety of your product, taking into account the requirements of DIN EN ISO 10993-1, -17 and -18. The BER is a key part of the technical documentation as defined in MDR Annexes II and III.
Training Courses
For companies in the food, pharmaceutical, medical device and healthcare industries, continuing education and training for professionals and career changers is critical. This is because standards and legislation are constantly changing and manufacturers, processors and operators need to keep up to date.
Specifics in the food sector
Our training programmes
BIOSERV offers a wide range of training courses for employees in the food industry, particularly in the area of quality assurance. In addition to in-house consultancy, BIOSERV also offers online training courses. The modular training courses are always tailored to individual needs.
Hygiene training and follow-up instruction in accordance with § 43 of german Infektionsschutzgesetz
Hygiene training and follow up instruction in accordance with Section 43 is mandatory for employees in food businesses and the employer is responsible for providing it. All employees who come into contact with food must be trained annually in food hygiene and every two years in infection control.
Duration
approx. 60 minutes
Training dates
28 January 2025, 6 May 2025
Minimum number of participants
6 people*
Fee
59.00 plus VAT
Basic knowledge of prepacked product labelling
The seminar is aimed at food business operators or employees who are responsible for the labelling of pre-packed products for the end consumer.
Duration
approx. 3 hours
Training dates
13. March, 12. June, 19. September und 5. December 2025
Minimum number of participants
On request
Fee
On request
Introduction to the assessment of biological safety of medical devices (DIN EN ISO 10993)
Biological safety is critical to the successful approval of a medical device. According to Annex I of the MDD, products must fulfil essential safety and performance requirements. This means that they must be biocompatible and not cause toxic effects, inflammation or other adverse reactions.
Duration
approx. 6 hours
Available dates
On request
Minimum number of participants
On request
Kosten
Auf Anfrage
