When product quality matters...
Chrysalide Services, for safe and effective medical devices.
Services for manufacturers
Patient safety is paramount when it comes to medical devices. To ensure this safety, it is essential to anticipate the challenges that arise and respond quickly to any situation. That is why we offer you personalised services that can be adapted to your needs, with the flexibility of a small structure able to support you quickly.
Management system
Your company's organisation is at the heart of quality. We can help you implement ISO13485 in line with the requirements of the MDR (EU), QSR (USA) or MDSAP (multiple countries).
Training
Our training modules are tailored to your needs, ranging from individual coaching to group training to make Nicolas Boileau's (1636-1711) quote your own:
" What is well conceived is clearly expressed. And the words to say it come easily ."
" What is well conceived is clearly expressed. And the words to say it come easily ."
Regulation
Regulatory requirements are many and varied. We help you establish and maintain compliance of your medical devices for your target markets.
Support
Faced with a critical situation, a temporary lack of QA/RA resources or knowledge, we help you find a solution, quickly.
Services for subcontractors and suppliers
Are your activities important, even critical, for the medical device manufacturers you serve? That is why we offer you personalized services that will make you a reliable partner, able to meet the needs of your customers.
Management system
Your company's organisation is at the heart of quality. We can help you implement ISO13485 or ISO9001 in line with your position as supplier or subcontractor.
Formation
Our training modules are tailored to your needs, ranging from individual coaching to group training to make Nicolas Boileau's (1636-1711) quote your own:
" What is well conceived is clearly expressed. And the words to say it come easily ."
" What is well conceived is clearly expressed. And the words to say it come easily ."
Regulation
Regulatory requirements are numerous and varied. We summarize for you the points to master to be a reliable partner.
Support
Faced with a critical situation, a temporary lack of QA/RA resources or knowledge, we help you find a solution, quickly.
ABOUT ... the company
Chrysalide Services was founded in 2008 to help companies improve their Quality System and their products. We focus particularly on medical device manufacturers as well as their suppliers and subcontractors.
Chrysalide Services is a micro-enterprise that has a network of professionals with diverse and complementary skills. This allows us to be responsive and flexible while offering very competitive rates.
EXPERTISE
- Clinical & Regulatory Strategy
- PRRC, authorized representives (EU, CH,...)
- EUDAMED (EU), FURLS & GUDID (USA), Swissdamed (CH)
- Usability (IEC62366), risk management (ISO14971), UDI, labelling & IFU, reprocessing process (Sterilizable MD), IQ/OQ/PQ
- Postmarket surveillance, PMCF, PSUR, SSCP
- Technical files (EU), DHF & DMR (USA), STED, CSDT
- CAPA and change management (MD & system)
- Internal and supplier audit, preparation for external audits and inspections
ABOUT ... the team
Alain Leonetti
Co-founder, Manager and QA/RA Consultant
alain.leonetti@chrysalide-services.ch
With over 20 years of experience in the medical device industry, I am passionate about the challenge of innovating in a highly regulated field. Many questions arise before, during and after product design :
- What are the technical choices for creating a safe and effective medical device ?
- Where to place the cursor between subcontracting and internal manufacturing ?
- What skills and certifications are required to master the products ?
- What regulatory pathways exist to obtain the right to market a medical device ?
- And what now ?
So many complex questions where my experience can help you find answers adapted to your situation.
Before joining the medical device field, I worked for 15 years in various high-tech product manufacturing companies.
Contact Us
Email us at contact@chrysalide-services.ch or use the contact form.