Services
The vision of D’Silva Medical Device Consulting is to bring talent, ideas, experts, and innovation together.
Production & Manufacturing
Currently working with a group of established Contract and Legal Manufacturers worldwide the option to introduce your product at all stages of its development lifecycle is possible.
- Contract Manufacturing
- Legal Manufacturing
- Own Equipment Manufacturing
- R&D Manufacturing
Quality Management System
D’Silva and his team have a significant level of QMS experience to support any aspect of your requirements. This experience extends to various global markets including Brazil, Japan, Hong Kong & Argentina. The quality team consists of certified Lead auditors for both ISO 13485 and MDSAP. In addition, they are also significantly experienced in the implementation of various eQMS platforms and in helping your company work within a lean paperless environment if required.
- QMS Set-up & Implementation
- eQMS implementation and customization
- Quality Manual, Quality Policy, Mission & Vision creation
- QMS integration assistance for mergers and acquisitions
- Audit/inspection readiness assessment
- Risk management per ISO 14971
- Supplier management
- Remediation of audit/inspection non-conformities and 483s (incl. supporting root cause analysis, definition of actions and effectiveness evaluation)
Clinical Trials & Clinical Evaluations
Clinical Investigations
The requirements for clinical evidence within the CE conformity assessment process of medical devices have further increased. Under the European Medical Device Regulation (2017/745) (MDR), there are important new requirements for pre-market and post-market clinical investigations. Benefit from a group of clinical professionals and experts in the field with a history of hands-on clinical investigation experience to support you in generating, collecting and updating clinical data for the entire life cycle of your product. The experts we work with have over 20 years of experience and will be sure to act as a guide and provide the required advice to help you understand and correctly apply all regulatory requirements. Clinical trial support can be organised in Germany, Austria, Switzerland, Netherlands, Belgium & Lithuania.
Clinical Evaluations
Our experts will prepare for you the clinical evaluation plan (CEP) and clinical evaluation report (CER) for all classes of medical devices (Class I, IIa, IIb, III) according to the requirements of the MDR. The creation and linkage of the relevant Periodic Safety Update Report (PSUR) and Summary of Safety and Clinical Performance (SSCP) is also available upon request.
- Clinical Evaluation Planning
- Clinical Evaluation Reports
- Clinical Investigations
- Competent Authority & Ethics Committee Submissions
- Guideline & Procedure development
- Patient Informed Consent & Case Report Form development
- Post-Market Clinical Follow-up Studies
- Periodic Safety Update Reporting (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
REGULATORY AFFAIRS - Regulatory Strategy & Submissions
D’Silva and his team have a significant level of regulatory experience to support a wide range of regulatory requirements. This experience extends to various global markets including Brazil, Japan, Hong Kong, Canada, Switzerland, UK & Argentina. The regulatory team consists of certified Lead auditors for both ISO 13485 and MDSAP which ensures that all regulatory aspects are overseen with the required quality specific aspects.
- Device Classification
- EUDAMED - Registrations & Activities
- PRRC
- Regulatory Strategy - EU & FDA
- FDA submissions (510(k), PMA, De Novo, IDE)
- EU Submissions & CE marking - MDR (EU 2017/745) & IVDR (EU 2017/746)
- EU, FDA, Hong Kong, Brazil, Japan, Argentina, UK & Switzerland product registrations
- Change Notifications
- Technical Documentation gap assessments
- Technical Documentation Annual Updates
- Importing & Authorized Representative Support & Set-up
- Labelling & Marketing material creation
- Unique Device Identification (UDI)
Prototyping, Research & Development
Through the network of D’Silva’s strategic partners, a wide range of experience in product design and development is available to support your idea from early-stage R&D concepts, to a functional prototype. These services are accompanied by all the required documentation according to EU MDR, ISO 13485 and the FDA. This provides you with the possibility to scale up your prototype into either pilot production, clinical trial builds or even serial manufacturing. At each phase of the design and development of your product, the associated design verification & validation testing is also available. The possibility to also have a dedicated project manager to facilitate the coordination with all the involved cross functional activities is also available upon request.
- Concept & Ideation
- Prototyping & Testing
- Project Development Planning
- Engineering Documentation according to EU MDR, ISO 13485 & FDA
- Program Management
Biocompatibility, Hazardous Substances, Sterilization & Cleanroom Expertise
The experts working with D’Silva Medical Device Consulting are equipped with multiple years of experience and can readily contribute to the required biological evaluation strategies, toxicological risk assessments, risk assessments of materials & substances in accordance with REACH and RoHS under the framework of the Medical Device Regulation (MDR), ISO 10993-series, FDA and other country specific relevant regulatory guidelines/requirements. The service includes assistance and communication for the respective biocompatibility studies performed at various contract laboratories and communication with the FDA and CE certification bodies if required. The team is able to assist with projects at all stages of their product life cycle.
In addition to the skill set of biocompatibility, the team is also experiences in the areas of Particulate testing, Sterilization and Cleanroom Expertise (Set-up and monitoring). For further detailed information or any specific requirements, please do not hesitate to use the contact form.
- Concept & Ideation
- Prototyping & Testing
- Project Development Planning
- Engineering Documentation according to EU MDR, ISO 13485 & FDA
- Program Management
D´Silva supports all stages of medical device development for access to the European, Asian, Latin American, Canadian, and U.S Markets.