Faster Market Approval
We navigate you safely through MDR, IVDR, GMP and FDA requirements:
reliable, compliant, and efficient.
Laura Jensen
Compliance Specialist / Consultant
Efficient certification of medical devices and pharmaceuticals
The certification of medical devices and pharmaceutical products presents manufacturers with complex regulatory challenges. MDR and IVDR, GMP requirements, additional national regulations and international market access conditions create a wide range of rules and prerequisites. With our Lean Regulatory Compliance approach, we guide you from product idea to successful market access, ensuring efficiency, risk minimization and proven results.
We integrate regulatory requirements early into your development and manufacturing processes, support your projects in a structured way and ensure that technical documentation is complete, MDR compliant and GMP ready. Even after market launch, we support you with vigilance, post-market surveillance, the resolution of non-conformities and the processing of CAPAs.
Whether gap analysis, mock audit or FDA inspection, we ensure that your conformity strategy is clearly defined, risks are minimized and resources are used effectively. Our expertise covers all phases, from defining intended use and classification to conformity assessment and international product registration in both medical technology and pharmaceuticals, including the Big 5 markets EU, USA, Japan, Canada and Brazil, as well as China.
Together with your team, we ensure regulatory compliance and accelerate the market introduction of your products. This creates more market dynamics, fewer authority queries and sustainable market success.
Technical Documentation
Structured and audit-ready documentation – compliant with MDR, IVDR and GMP. Efficient, without delays and unnecessary re-requests.
International Presence
Market access for medical devices and pharmaceuticals in EU, USA, China, Japan, Canada and Brazil, including FDA inspections and registrations.
Efficiency and Safety
Early classification, structured project flow and risk-based resource planning in MedTech and Pharma.
Meeting regulatory requirements in product development efficiently
Plan regulatory requirements early
The greatest potential savings in the certification of medical devices arise when regulatory requirements are considered even before the project starts. We support teams from R and D and Regulatory Affairs in clearly defining all compliance relevant work packages and integrating them into the project flow. This reduces rework, cuts iterations and raises planning reliability.
Secure customer processes in a regulatory way
Regulatory requirements in customer management have a direct impact on satisfaction. In life sciences, vigilance, post market surveillance and reporting are important as well. We analyse your customer related processes, define clear procedures and integrate them into your quality management system, including modern solutions such as IoMT or customer portals.
Check technical documentation before submission
Is the supporting documentation complete? A targeted compliance check of the technical documentation before submission to the notified body helps to identify regulatory gaps early. We know the requirements of notified bodies and authorities and prepare your documents accordingly.
Structured project support
Clear responsibilities and processes for product development and conformity assessment save time and cost. We identify optimisation opportunities along the development process with a risk based approach that keeps the focus on what really matters.
From idea to approval
We guide you through every phase of product certification with a clear structure, regulatory expertise and practical solutions.
Our services: Gap analysis, target market strategy and compliance planning.
Details: Early identification of regulatory requirements, correct classification for the target market and a solid compliance strategy.
Our services: MDR compliant documentation, clinical evaluation.
Details: Creation or revision of technical documentation including safety and performance characteristics, instructions for use and clinical evaluations.
Our services: Mock audits, audit support, gap analysis.
Details: Specific preparation for audits by notified bodies, the FDA or authorities. Realistic mock audits reveal weak points.
Our services: FDA and MDR approval, inspection support.
Details: Support for submission of technical documentation, approval strategy and preparation for FDA inspections or MDR reviews.
Our services: PMS systems, IoMT, customer portals.
Details: Practical PMS plans aligned with MDR, IVDR and ISO 20416, support for PMCF and integration of digital tools.
Our services: Efficient CAPA processes, customer integration, innovation.
Details: Analysis and optimisation of complaints and CAPA processes using lean principles with a focus on shorter cycle times.
Start your next product approval with us.
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