We provide integral support for all stages of product and software lifecycle, including in-vitro diagnostic products and medical device software (MDSW) in Europe and USA. With us, you can rest assured that your medical device (MD) regulatory compliance needs are taken care of, allowing you to focus on your core business objectives.
We deliver end-to-end support and solutions to ensure regulatory compliance for medical devices at every stage of the product cycle
Our Regulatory and Quality Solutions excel in providing end-to-end support and valuable advisory services, guaranteeing that your medical devices and medical device software (MDSW) adhere to regulatory standards at every stage of their lifecycle.
At the core of our strengths is the ability to offer intricately customisable services. From design and development to manufacturing, marketing, and post-marketing operations, our solutions are precisely tailored to meet the unique needs of our clients.
Experience streamlined compliance processes with our expert team's crafted roadmaps. This not only ensures adherence to regulations but also saves valuable time and resources for both startup ventures and multinational corporations.
Our commitment extends beyond compliance to an unwavering dedication to project success. Upholding regulatory standards is our priority, ensuring product safety and performance for the well-being of patients
and users.
We offer different services along the entire value chain of medical devices, aimed at meeting the quality objectives and regulatory requirements in each case.
For both new products and legacy medical devices, our consultants can facilitate regulatory consulting to place medical devices to market:
Regulatory Roadmaps
Medical Device classification
MDR / IVDR checklist readiness
Product Risk assessment: ISO 14971 methodology
Gap remediation of defficiencies from NB / Health Authority review / inspection
Ad-hoc consulting
Medical devices must be managed under a quality system throughout their life cycle. Our extensive Quality Management Systems (QMS) expertise will ensure that quality management processes are defined and/or improved, facilitating associated regulatory compliance and continuous improvement:
Implementation of QMS (ISO 13485 & 21 CFR 820): supporting you to QMS certification
Internal Audis/GAP Assessment: getting you ready for QMS certification
Suppliers Approval: supplier managements and worldwide supplier audit
QMS Certification back office
Non conformities and CAPA management
Be confident with your QMS and your outsourced activities and suppliers. Our consultants and auditors can bring you the best approach to improve internally and also to qualify your suppliers, especially critical suppliers that would also be audited by the Health Authorities:
QMS Internal Audits
FDA mock inspections
Notified Body back office support
QMS or Technical File gap assessments
Supplier audit/supplier qualification
Compilation of Technical Documentation following the specific regulatory strategy depending on the regional regulations. We also have significant experience in providing verification evidences such as for Medical Device Software (MDSW) and In Vitro Diagnostic (IVD) Medical Devices.:
Compilation of Technical DocumentationÂ
Define claims for intended use and device description chapter Product Risk assessment
How to evidence and justify General Safety and Performance Requirements (GSPR) and applicable standardsÂ
Review of labels and Instructions for Use
Design and Development Documentation
Functional verification for Medical Device SoftwareÂ
Analytical Performance for IVD products
Manufacturing/sterilisation process validation
Post Market Surveillance plans and reports
For small medical device and MDSW companies, we can act as the Person Responsible for Regulatory Compliance (PRRC), being permanently and continuously at your disposal.
We can work together to define how to proceed to ensure the responsibilities and also train a person within your organisation to acquire the needed experience to be the internal PRRC in the future.
Our experienced team of medical device consultants act as a partner ensuring regulatory compliance and quality assurance. We are driven by our enthusiasm to bring safe, effective and innovative medical devices to market.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
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