Concept to Launch > Ideas to Reality
Simplimedica supports short-term, medium-term, and long-term project work for small-medium-sized businesses, as well as large corporations which may have a shortage in a skill or wish to outsource work to improve productivity.
We help companies establish quality management systems (QMS) that are 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 is very well experienced to assist you whether you have someone on maternity leave or simply short on resources while headhunting for a perfect staff member in the capacity of Quality/Regulatory Manager or Director to ensure you still remain compliant and don’t compromise your quality system.
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 of the communications with notified bodies and manage the audits for full delivery of your ISO certificates.
It is the manufacturer’s responsibility to ensure that there is 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 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 own capabilities of testing or we can use our strong network of providers, laboratories, and test facilities to ensure your physical, biological, 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 both MDD, IVDD, and also 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 over years for all Medical Devices and continues to keep abreast of the everchanging regulatory landscape. The US FDA has over the recent years had many innovative device entry solutions making technology reach the users with less fuss. However, these options need careful exploration which Simplimedica is very well equipped with an understanding of these market entry requirements. Contact Us today for a no obligations discussion.
You may not need support in registering your device for commercialization in Europe or the USA, the rest of the world market 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, it’s inevitable that there may be some non-conformances picked up during the audit resulting in work that could have been avoided, so if you don’t hire Simplimedica to inspect your documentation prior to the 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.
Full-scale management for a startup to multinational business. Contact us below for a 30-minute confidential conversation regarding your quality assurance and regulatory affairs.