We are Regulatory Affairs Specialists for Medical Products
We ensure that your private label or medical products meet the regulatory requirements of the countries in which they are sold.
Regulatory affairs are an integral part of our OEM services. We are familiar with the standards, guidelines and procedures – and know what steps are necessary to ensure a safe, fast and predictable market launch.
Regulatory Affairs Management for National and International Markets
Regulatory affairs accompany every phase of product development at Becht: from the initial idea to approval and beyond, we develop successful approval strategies together with you.
We take care of all regulatory affairs management for the European and global markets for our partners and distributors. We obtain the necessary approvals, carry out registrations, manage all regulatory approvals and monitor compliance with all applicable regulations. At the same time, we ensure ongoing compliance throughout the entire life cycle of your product.
Your Advantages with Becht as a Regulatory Affairs Specialist
Becht creates the ideal conditions for rapid product launches in national and international markets. We take care of documentation, testing and approvals – so that your product can reach the market faster.
Becht translates your requirements into a robust efficacy and tolerability profile and, based on this, develops new formulations or optimises existing ones to precisely suit your target markets. Our ISO 13485 certification provides the formal framework for quality management at the highest level.
Becht accompanies the entire development phase with a view to providing complete technical documentation (DHF, DMR), structures the documents in accordance with MDR Annex II & III, and consistently documents design changes using established design controls. This results in complete, auditable documentation for the safe and effective market launch of your products.
Becht identifies regulatory hurdles at an early stage and works with you to develop measures that stabilise project progress and avoid delays. In this way, we reduce risks throughout the entire development and approval process.
As a manufacturer of high-quality medical products with over 100 years of experience, Becht has extensive knowledge of the relevant regulations in Europe and worldwide. This enables us to plan approval processes precisely and position medical products securely in different markets.
Becht takes on all regulatory tasks and provides your internal teams with lasting relief. This gives you planning security and creates space for those tasks that advance your core business.
With an eye on regulatory developments, the needs of our customers, their markets and social changes, we are constantly working on new, high-quality solutions and continuously optimising our formulations. This ensures that your product portfolio remains compliant, marketable and geared towards long-term success.
Becht's Regulatory Affairs Services
1. Product Idea + Risk Analysis
We analyse product classification, regulatory requirements and potential risks – thereby preventing undesirable developments or subsequent approval hurdles at an early stage with the following service modules:
- Classification in accordance with the Medical Device Regulation (MDR)
- Assessment of regulatory obligations (CE, Notified Body, scope of documentation)
- Preparation of risk analysis in accordance with ISO 14971
- Comparative analysis with existing products (regulatory benchmarks)
2. Development & Technical Documentation
We prepare all technical documentation and demonstrate regulatory compliance. Validated, auditable documentation is created in close cooperation with our research and development department.
- Support during the development phase with a view to complete technical documentation (DHF, DMR)
- Ensuring MDR-compliant test reports, material certificates and test strategies
- Compilation of technical documentation in accordance with MDR Annex II & III
- Consistent documentation of design changes (design controls)
3. Approval & Labelling
We provide support for MDR certification, CE marking and UDI processes – including preparation for all regulatory audits.
- Preparation and review of the declaration of conformity
- Preparation and support for audits by notified bodies
- UDI assignment, IFU approval and label review
- Preparation of the Summary of Safety and Clinical Performance (SSCP)
4. Market surveillance (PMS)
We take care of systematic market monitoring, trend analysis and risk management to ensure long-term compliance with regulatory requirements.
- Planning, implementation and documentation of all PMS activities
- Preparation of PMSR and PSUR
- Evaluation of feedback, complaints and incidents
- Initiation and monitoring of CAPA measures
since 1923
PIONEERS IN THE
MANUFACTURING
OF MEDICAL
QUALITY PRODUCTS
German Medical Quality
With us, comprehensive know-how meets the vision of providing the best products for everyday medical work.
As a certified German manufacturer, we stand for the highest quality, reliability and safety and effectiveness of our products.
We have been developing these in our company since 1923 in close cooperation with leading physicians from all over the world and manufacturing them ourselves in our production facilities.
GERMAN MEDICAL QUALITY made by Becht
Collaborative partnership from the idea to ready to sell products.
Your product is our focus. We know what is important. Alfred Becht GmbH is an OEM and ODM for medicine, industry, Horeca, municipalities, public institutions, food retail, trademarks.
Do you have an enquiry or a project that you would like to implement with us?
Your contact at Becht