Regulatory
Bringing medical devices to market can be complex, requiring an understanding of regulatory requirements and processes. Navigating regulatory affairs for medical devices can be a daunting challenge especially without the assistance of an established expert. Having to coordinate with myriad regulatory agencies each with its own requirements, regulations, and guidance can make product development and device approval a lengthy process. Working with an experienced team that has traveled this road before can significantly improve your chances of success.
Being familiar with the regulatory process and ever-changing guidance from the regulatory agencies, we can help our clients get devices to market more efficiently and effectively.
Biotex maintains an ISO-13485 quality system certification, allowing our clients to leverage our quality system infrastructure through the product development stages and beyond, saving time and expense of installing and maintaining their own system. After the development tasks are completed, we offer in-house regulatory expertise with experience in FDA and CE mark filings and requirements.
We work directly with regulatory agencies to get our client’s products approved for marketing. We can also work with the client's regulatory consultants or staff to provide support as needed. In addition, we offer strategic guidance at every stage of the product development process.
Biotex offers medical device companies the following services to expedite the regulatory process:
Regulatory Strategy
A well-crafted regulatory strategy considers international and FDA medical device regulations and development costs, cycles, and profitability concerns.
We will consider the current regulatory environment, relevant guidelines, and ongoing FDA and/or international medical device initiatives that could influence your regulatory pathway. Our medical device regulatory experts will also consider information about your medical device, including:
- Device description and specifications
- Intended clinical application(s)
- Labeling claims
- Available test data
- Literature references
We will review and identify possible predicate devices, standard methods, procedures and/or practices, regulatory submission guidance documents, and other applicable regulations and policies.
US Regulatory Services
- Pre-Market Notification — 510(k)
- Pre-Market Approval — PMA
- Investigational Device Exemption — IDE (for clinical studies)
- Establishment Registration and Device Listing
- Strategy, Agency Meetings
Canadian Regulatory Services
- Medical Device License Applications (Class II, III, IV)
- Investigational Testing Authorizations (for clinical studies)
- Medical Device Establishment Licenses
- Strategy, Agency Meetings
EU Regulatory Services
- Technical File, Design Dossier Preparation
- Clinical Evaluations
- CE Mark Facilitation
Quality Systems
- Quality systems to meet ISO 13485, US QSR, and regulations for US, Canada, and EU
- Internal and Supplier Audits