Concept to Launch > Ideas to Reality
Simplimedica supports short-term, medium-term, and long-term project work for small and medium-sized businesses, as well as large corporations that may have a shortage in a skill or wish to outsource work to improve productivity.
We help companies establish quality management systems (QMS) compliant with medical device industry standards. We also provide guidance where regulatory requirements can be overwhelming and confusing. Simplimedica is a one-stop solution for ensuring that your company’s medical devices are firmly on track for being approved for sale in target markets.
Ensure medical devices meet the required high standards
As IRCA-certified auditors, we are capable of taking on internal auditing responsibilities, as well as performing your external audits of suppliers & customers. We can also perform mock audits of your technical documentation prior to submission.
Simplimedica is also very well experienced in remediating documentation where external audits have caused nonconformances or CAPAs.
Simplimedica are very experienced in assisting you whether you have someone on maternity leave or are simply short on resources while headhunting for the perfect staff member in the capacity of Quality/Regulatory Manager or Director to ensure you remain compliant and don’t compromise your quality systems.
We have implemented dozens of ISO 13485 QMS Systems and can quickly have you up and running from scratch with a fully compliant system. We will also take care of all communications with notified bodies and manage the audits for delivery of your ISO certificates.
It is the manufacturer’s responsibility to ensure that there are adequate validation of all processes involved in the production of any of these products. We cater for equipment, cleaning and process validation, laboratory as well as test method validation.
Validating a process from beginning to end is a daunting task that can involve an entire trail of quality assurance, not only of the equipment involved in the production of your product but also of storage conditions. Process validation should verify that procedures and processes used in the manufacturing of your product, are suitable for their purposes and guarantee that the process used will consistently meet its predetermined specifications and quality characteristics. The procedure must outline the way of carrying out an activity. The process is a set of methods and actions which interact to convert what goes into what comes out.
Simplimedica has over 20 years of experience with validations.
As part of managing your entire submissions, Simplimedica can ensure your design plan is in place and followed. We can project manage all elements of design & development, including inputs & outputs and ensure all verification and validation activities take place either with your capabilities of testing or we can use our strong network of providers, laboratories, and test facilities to ensure your physical, biological and chemical testing has satisfied the correct regulatory requirements to ensure your devices has met the safety characteristics needed.
Guide clients to meet regulatory requirements
No challenge is too big!
Simplimedica has years of experience with CE marking devices under MDD, IVDD, and more recently, the MDR and IVDR classifications. Your device may be –
- Sterile/Non-Sterile
- Invasive/ Non Invasive
- Active/ Active Implantable
- Software
- Drug-Device combination
- Biologic
- Point of care/self test
- IVD
We have worked with all device combinations. Please check in with us today to confirm that your product is a Medical Device and what the next steps to conformity are.
Simplimedica has created several design history files for all medical devices and continues to keep abreast of the ever-changing regulatory landscape. The US FDA has over recent years had many innovative device entry solutions making technology reach end-users with less fuss. However, these options need careful exploration and Simplimedica is well equipped with an understanding of these market entry requirements.
Contact Us today for a no-obligation discussion.
You may not need support in registering your device for commercialisation in Europe or the USA, however, the rest of the world still constitutes just under 50% of the global market. So you may wish to market your device in Brazil, Canada, China, Japan, Australia, Middle East, Africa, or other territories.
Simplimedica will ensure your regional territories are covered and work with external legal services to naturalize or endorse any documentation.
While we love to have flawless audits, there may inevitably be some non-conformance issues picked up during the audit resulting in work that could have been avoided, so if you don’t hire Simplimedica to inspect your documentation before an audit then you may consider our services to remediate any documentation to bring it up to the correct standards.
Better late than never! Contact us today.
From full-scale management for a startup to a multi-national business. Contact us below for a FREE 30-minute confidential conversation regarding your quality assurance and regulatory affairs.